ExpeditionPRO: A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02760602
• Collaborator: (none)
• Enrollment: 26
• Locations: 193
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 0.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: Solanezumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Solanezumab Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.	Drug: Solanezumab; Administered IV; Other Names: LY2062430
Experimental: Placebo Placebo given IV once every 4 weeks for up to 2 years.	Drug: Placebo; Administered IV

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score [Baseline, 24 Months]

   ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.

Secondary Outcome Measures

1. Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) [Baseline, 24 Months]

   The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.

2. Change From Baseline on the Mini Mental Status Examination (MMSE) [Baseline, 24 Months]

   MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.

3. Change From Baseline on the Montreal Cognitive Assessment (MoCA) [Baseline, 24 Months]

   The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.

4. Change From Baseline on the Functional Activities Questionnaire (FAQ) [Baseline, 24 Months]

   FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment.

5. Change From Baseline on the Neuropsychiatric Inventory (NPI) [Baseline, 24 Months]

   The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity.

6. Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [Baseline, 24 Months]

   CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.

7. Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Baseline, 24 Months]

   RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.

8. Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT) [Baseline, 24 Months]

   The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.

9. Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite) [Baseline, 24 Months]

   RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.

10. Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D) [Baseline, 24 Months]

    EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity.

11. Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD) [Baseline, 24 Months]

    QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL.

12. Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab [Baseline, 24 Months]

    Concentration of amino acid peptide known as Aβ 1-42 in plasma.

13. Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) [Baseline, 24 Months]

    MRI will be used to assess the effect of treatment on rate of whole brain volume.

14. Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr) [Baseline, 24 Months]

    Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.

15. Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins [Baseline, 24 Months]

    Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.

16. Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET [Baseline, 24 Months]

    Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.

• Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.

• Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.

• Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).

• Scores >0 on the Functional Activities Questionnaire (FAQ).

• Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology.

Exclusion Criteria:

• Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.

• Has known allergy to humanized monoclonal antibodies.

• Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.

• Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.

• Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.

• Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xenoscience	Phoenix	Arizona	United States	85004
2	Banner Alzheimer's Institute	Phoenix	Arizona	United States	85006
3	St Josephs Hospital and Medical Center	Phoenix	Arizona	United States	85013
4	Banner Sun Health Research Institute	Sun City	Arizona	United States	85351
5	Center for Neurosciences	Tucson	Arizona	United States	85718
6	Arizona Health Sciences Center	Tucson	Arizona	United States	85724
7	Parexel Early Phase Unit at Glendale	Glendale	California	United States	91206-4140
8	Pacific Neuroscience Medical Group	Oxnard	California	United States	93030
9	Desert Valley Research	Rancho Mirage	California	United States	92270
10	Pacific Research Network Inc	San Diego	California	United States	92103
11	Sharp Mesa Vista Hospital	San Diego	California	United States	92123
12	California Pacific Medical Center	San Francisco	California	United States	94114
13	Apex Research Institute	Santa Ana	California	United States	92705
14	Care Access Research LLC	Santa Clarita	California	United States	91321
15	California Neuroscience Research	Sherman Oaks	California	United States	91403
16	Care Access Research	Valencia	California	United States	91355
17	MCB Clinical Research Centers	Colorado Springs	Colorado	United States	80910
18	Mile High Research Center	Denver	Colorado	United States	80218
19	Yale University School of Medicine	New Haven	Connecticut	United States	06510
20	New England Institute for Clinical Research	Stamford	Connecticut	United States	06905
21	Christiana Care Research Institute	Newark	Delaware	United States	19713
22	Brain Matters Research	Delray Beach	Florida	United States	33445
23	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida	United States	33912
24	Sunrise Clinical Research	Hollywood	Florida	United States	33021
25	Clinical Neuroscience Solutions Inc	Jacksonville	Florida	United States	32256
26	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
27	Miami Jewish Health Systems	Miami	Florida	United States	33137
28	Suncoast Clinical Research	New Port Richey	Florida	United States	34652
29	Sensible Healthcare	Ocoee	Florida	United States	34761
30	Compass Research	Orlando	Florida	United States	32806
31	Pensacola Research Consultants, Inc.	Pensacola	Florida	United States	32502
32	Quantum Laboratories	Pompano Beach	Florida	United States	33064
33	Roskamp Institute	Sarasota	Florida	United States	34243
34	Axiom Research	Tampa	Florida	United States	33609
35	Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida	United States	33407
36	Atlanta Center of Medical Research	Atlanta	Georgia	United States	30331
37	United Osteoporosis Center	Gainesville	Georgia	United States	30501
38	Christie Clinic, LLC	Champaign	Illinois	United States	61820
39	Alexian Brothers Medical Center	Elk Grove Village	Illinois	United States	60007
40	Central DuPage Hospital	Winfield	Illinois	United States	60190
41	Fort Wayne Neurological Center	Fort Wayne	Indiana	United States	46804
42	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202
43	Josephson Wallack Munshower Neurology	Indianapolis	Indiana	United States	46256
44	Cotton O'Neil Clinic	Topeka	Kansas	United States	66606
45	Heartland Research Associates	Wichita	Kansas	United States	67207
46	Baptist Health Medical Group	Lexington	Kentucky	United States	40503
47	Lake Charles Clinical Trials	Lake Charles	Louisiana	United States	70629
48	Maine Neurology	Scarborough	Maine	United States	04074
49	Sheppard Pratt Health System	Baltimore	Maryland	United States	21204
50	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21205
51	PharmaSite Research Inc	Baltimore	Maryland	United States	21208
52	Sheppard Pratt Health System	Baltimore	Maryland	United States	21285
53	ActivMed Practices & Research, Inc	Methuen	Massachusetts	United States	01844
54	Donald S Marks	Plymouth	Massachusetts	United States	02360-4843
55	QUEST Research Institute	Farmington Hills	Michigan	United States	48334
56	Hattiesburg Clinic	Hattiesburg	Mississippi	United States	39401
57	ClinVest	Bolivar	Missouri	United States	65613
58	Clinical Research Professionals	Chesterfield	Missouri	United States	63141
59	Millenium Psychiatric Associates LLC	Creve Coeur	Missouri	United States	63141
60	St Lukes Hospital	Kansas City	Missouri	United States	64111
61	Las Vegas Medical Research	Las Vegas	Nevada	United States	89113
62	Healthy Perspectives Innovative Mental Health Services, PL	Nashua	New Hampshire	United States	03060
63	ActivMed Practices & Research, Inc	Portsmouth	New Hampshire	United States	03801
64	Memory Enhancement Center of America, Inc.	Eatontown	New Jersey	United States	07724
65	Pyramid Clinical Research	Monroe	New Jersey	United States	08831
66	Princeton Medical Institute	Princeton	New Jersey	United States	08540
67	The Cognitive and Research Center of NJ	Springfield	New Jersey	United States	07081
68	Advanced Memory Research Institute of New Jersey	Toms River	New Jersey	United States	08755
69	Bio Behavioral Health	Toms River	New Jersey	United States	08755
70	Albany Medical College	Albany	New York	United States	12206
71	Richmond Behavorial Associates	Staten Island	New York	United States	10312
72	Alzheimer's Memory Center	Charlotte	North Carolina	United States	28270
73	Piedmont Medical Research	Winston-Salem	North Carolina	United States	27103
74	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
75	Neurology Diagnostics, Inc.	Dayton	Ohio	United States	45459
76	Insight Clinical Trials	Shaker Heights	Ohio	United States	44122
77	Summit Research Network Inc	Portland	Oregon	United States	97210
78	Center for Cognitive Health	Portland	Oregon	United States	97225
79	Abington Neurological Associates	Abington	Pennsylvania	United States	19090
80	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
81	Lehigh Center for Clinical Research	Allentown	Pennsylvania	United States	18104
82	Clinical Trial Center, LLC, Psychiatry	Jenkintown	Pennsylvania	United States	19046
83	Northeastern Pennsylvania Memory & Alzheimer's Center	Plains	Pennsylvania	United States	18705
84	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island	United States	02914
85	Butler Hospital	Providence	Rhode Island	United States	02906
86	Metrolina Neurological Research Institute	Indian Land	South Carolina	United States	29707
87	Baylor AT&T Memory Center	Dallas	Texas	United States	75219
88	Baylor AT&T Memory Center	Dallas	Texas	United States	75231
89	FutureSearch Trials	Dallas	Texas	United States	75231
90	Houston Methodist	Houston	Texas	United States	77030
91	University of Texas Health Services Center - Houston	Houston	Texas	United States	77054
92	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
93	Univ of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
94	The Memory Clinic	Bennington	Vermont	United States	05201
95	Sentara Medical Group	Norfolk	Virginia	United States	23510
96	National Clinical Research - Richmond	Richmond	Virginia	United States	23294
97	Evergreen Professional Plaza	Kirkland	Washington	United States	98034
98	Dean Foundation for Health Research and Education	Middleton	Wisconsin	United States	53562
99	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Gatineau		Canada	J8T 8J1
100	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Greenfield Park		Canada	J4V 2J2
101	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Halifax		Canada	B3S1M7
102	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Kentville		Canada	B4N 4K9
103	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	London		Canada	N6C 0A7
104	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Ottawa		Canada	KIN 5C8
105	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Peterborough		Canada	K9H2P4
106	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Sherbrooke		Canada	J1H1Z1
107	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Toronto		Canada	M3B 2S7
108	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kuopio		Finland	70210
109	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Oulu		Finland	90100
110	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tampere		Finland	33100
111	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Turku		Finland	20014
112	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Vaasa		Finland	65130
113	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Amiens		France	80054
114	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bordeaux		France	33076
115	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bron		France	69677
116	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lille		France	59037
117	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Marseille		France	13385
118	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Montpellier		France	34295
119	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Paris		France	75010
120	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Paris		France	75015
121	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Paris		France	75651
122	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Rennes		France	35033
123	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Strasbourg		France	67000
124	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Toulouse		France	31059
125	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Chemnitz		Germany	09131
126	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Genova		Italy	16132
127	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Milano		Italy	20122
128	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Milano		Italy	20133
129	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Monza		Italy	20052
130	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pavia		Italy	27100
131	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Perugia		Italy	06134
132	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pisa		Italy	56126
133	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Roma		Italy	00153
134	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Roma		Italy	00161
135	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Roma		Italy	00179
136	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Roma		Italy	00189
137	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bunkyo-ku		Japan	113-8431
138	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bunkyo-ku		Japan	113-8655
139	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hachioji		Japan	193-0998
140	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hyogo		Japan	673-0848
141	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kamakura		Japan	247-8533
142	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kodaira-shi		Japan	187-8551
143	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Koriyama		Japan	963-8052
144	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kyoto-shi		Japan	607-8113
145	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mitaka-shi		Japan	181-0013
146	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Shinjuku-Ku		Japan	160-8582
147	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Shizuoka		Japan	424-0911
148	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Takamatsu		Japan	760-8557
149	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tokyo		Japan	113-0034
150	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tsu-shi		Japan	514-8507
151	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Białystok		Poland	15-732
152	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bydgoszcz		Poland	85-796
153	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lublin		Poland	20-093
154	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Poznan		Poland	30-856
155	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sopot		Poland	81-824
156	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warszawa		Poland	01-697
157	Santa Cruz Behavioral PSC	Bayamón		Puerto Rico	00961-6911
158	Cortex, PSC	Las Piedras		Puerto Rico	00771
159	University Of Puerto Rico	Rio Piedras		Puerto Rico	00936
160	Instituto de Neurologia Dra. Ivonne Fraga	San Juan		Puerto Rico	00918
161	Latin Clinical Trial Center	San Juan		Puerto Rico	00918
162	SomniCare Sleep Institute	San Juan		Puerto Rico	00918
163	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Barcelona		Spain	08014
164	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Barcelona		Spain	08025
165	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Barcelona		Spain	08036
166	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Castellon de la Plana		Spain	12004
167	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Getafe		Spain	28905
168	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Getxo		Spain	48993
169	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Madrid		Spain	28006
170	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Plasencia		Spain	10600
171	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Salt		Spain	17190
172	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Sebastian		Spain	20009
173	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Valencia		Spain	46017
174	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Valencia		Spain	46026
175	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Malmö		Sweden	20502
176	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mölndal		Sweden	43141
177	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Stockholm		Sweden	113 61
178	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Umeå		Sweden	90105
179	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Changhua		Taiwan	500
180	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gwei Shan Township		Taiwan	333
181	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Jhonghe City		Taiwan	235
182	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kaohsiung		Taiwan	80756
183	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kaohsiung		Taiwan	83301
184	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Taichung		Taiwan	40447
185	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tainan		Taiwan	70403
186	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Taipei		Taiwan	10048
187	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Taipei		Taiwan	11217
188	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bath		United Kingdom	BA1 3NG
189	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Chelsea		United Kingdom	W6 8RF
190	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Guildford		United Kingdom	GU2 7YD
191	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	London		United Kingdom	W1G 9RU
192	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Manchester		United Kingdom	M13 9WL
193	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Scotland		United Kingdom	G20 0XA

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Study Protocol - Mar 28, 2016
• Statistical Analysis Plan - Mar 8, 2017

More Information

Additional Information:

• Click here for more information about this study: A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02760602
• Other Study ID Numbers: 16349; H8A-MC-LZBE; 2016-000108-27
• First Posted: May 3, 2016
• Last Update Posted: Oct 10, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Eli Lilly and Company: anti-amyloid; monoclonal antibody
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

Participant Flow

Pre-assignment Detail	Participants were randomized by site and by use of florbetapir positron emission tomography (PET) scanning or cerebrospinal fluid (CSF) for study eligibility.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Period Title: Overall Study
STARTED	13	13
COMPLETED	0	0
NOT COMPLETED	13	13

Baseline Characteristics

Arm/Group Title	Solanezumab	Placebo	Total
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.	Total of all reporting groups
Overall Participants	13	13	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.46 (6.01)	75.62 (4.93)	74.54 (5.49)
Sex: Female, Male (Count of Participants)
Female	4 30.8%	6 46.2%	10 38.5%
Male	9 69.2%	7 53.8%	16 61.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	12 92.3%	13 100%	25 96.2%
Unknown or Not Reported	1 7.7%	0 0%	1 3.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 23.1%	0 0%	3 11.5%
Native Hawaiian or Other Pacific Islander	1 7.7%	0 0%	1 3.8%
Black or African American	0 0%	1 7.7%	1 3.8%
White	9 69.2%	12 92.3%	21 80.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	10 76.9%	11 84.6%	21 80.8%
Japan	2 15.4%	0 0%	2 7.7%
Canada	1 7.7%	0 0%	1 3.8%
Poland	0 0%	2 15.4%	2 7.7%
ADAS-Cog14 at Baseline (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	24.08 (8.00)	27.77 (3.63)	25.92 (6.37)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Description	ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

2. Secondary Outcome

Title	Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
Description	The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

3. Secondary Outcome

Title	Change From Baseline on the Mini Mental Status Examination (MMSE)
Description	MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

4. Secondary Outcome

Title	Change From Baseline on the Montreal Cognitive Assessment (MoCA)
Description	The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

5. Secondary Outcome

Title	Change From Baseline on the Functional Activities Questionnaire (FAQ)
Description	FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

6. Secondary Outcome

Title	Change From Baseline on the Neuropsychiatric Inventory (NPI)
Description	The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

7. Secondary Outcome

Title	Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Description	CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

8. Secondary Outcome

Title	Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Description	RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

9. Secondary Outcome

Title	Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)
Description	The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

10. Secondary Outcome

Title	Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)
Description	RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

11. Secondary Outcome

Title	Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)
Description	EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

12. Secondary Outcome

Title	Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)
Description	QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

13. Secondary Outcome

Title	Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab
Description	Concentration of amino acid peptide known as Aβ 1-42 in plasma.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

14. Secondary Outcome

Title	Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)
Description	MRI will be used to assess the effect of treatment on rate of whole brain volume.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

15. Secondary Outcome

Title	Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)
Description	Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

16. Secondary Outcome

Title	Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins
Description	Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

17. Secondary Outcome

Title	Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET
Description	Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
Time Frame	Baseline, 24 Months

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as no data collected.

Arm/Group Title	Solanezumab	Placebo
Arm/Group Description	Solanezumab given IV once every 4 weeks for up to 2 years.	Placebo given IV once every 4 weeks for up to 2 years.
Measure Participants	0	0

Adverse Events

Time Frame	Baseline to Study Termination (Up To 11 Months)
Arm/Group Title	Solanezumab		Placebo
Arm/Group Description	Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.		Placebo given IV once every 4 weeks for up to 2 years.
All Cause Mortality
	Solanezumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)
Serious Adverse Events
	Solanezumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/13 (15.4%)		1/13 (7.7%)
Cardiac disorders
Coronary artery disease	1/13 (7.7%)	1	0/13 (0%)	0
Infections and infestations
Pneumonia	0/13 (0%)	0	1/13 (7.7%)	1
Nervous system disorders
Syncope	1/13 (7.7%)	1	0/13 (0%)	0
Other (Not Including Serious) Adverse Events
	Solanezumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/13 (53.8%)		1/13 (7.7%)
Cardiac disorders
Coronary artery disease	1/13 (7.7%)	2	0/13 (0%)	0
Gastrointestinal disorders
Constipation	1/13 (7.7%)	1	0/13 (0%)	0
General disorders
Extravasation	1/13 (7.7%)	2	0/13 (0%)	0
Infections and infestations
Upper respiratory tract infection	2/13 (15.4%)	2	1/13 (7.7%)	1
Viral upper respiratory tract infection	1/13 (7.7%)	1	0/13 (0%)	0
Injury, poisoning and procedural complications
Fall	1/13 (7.7%)	1	0/13 (0%)	0
Skin abrasion	1/13 (7.7%)	4	0/13 (0%)	0
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis	1/13 (7.7%)	1	0/13 (0%)	0
Psychiatric disorders
Insomnia	1/13 (7.7%)	1	0/13 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension	1/13 (7.7%)	1	0/13 (0%)	0
Upper-airway cough syndrome	0/13 (0%)	0	1/13 (7.7%)	1
Surgical and medical procedures
Endodontic procedure	1/13 (7.7%)	1	0/13 (0%)	0

Limitations/Caveats

The study was terminated due to insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to pts with prodromal AD as defined by the study protocol. Zero pts were analyzed as no data collected for outcomes.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.