Autonomy: A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04619420
• Collaborator: (none)
• Enrollment: 420
• Locations: 144
• Arms: 2
• Anticipated Duration (Months): 58
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Cognitive Dysfunction; Dementia	Drug: JNJ-63733657; Drug: Placebo	Phase 2

Detailed Description

Alzheimer's disease (AD) is a fatal neurodegenerative disease that is manifested by progressive cognitive deficits including memory loss followed by loss of independent function as well as neuropsychiatric symptoms such as apathy, depression, anxiety, agitation and psychosis. JNJ-63733657 is a humanized monoclonal anti-tau antibody which binds to phosphorylated tau (P-tau). The study will evaluate whether JNJ-63733657 can slow clinical (cognitive and functional) decline in participants with Early AD with evidence of elevated brain tau (T+) and assess its safety and tolerability. The study consists of: screening period (13 weeks), double-blind treatment period (up to 232 weeks), and a follow-up period (13 weeks). Safety and tolerability assessments will include adverse events (AEs), vital signs, electrocardiogram (ECG), early discontinuations, physical and neurological examinations, safety laboratory evaluations, suicidality risks (Columbia Suicide Severity Rating Scale [CSSRS]) and brain MRI will be performed during the study. The maximum treatment duration is up to 232 weeks (4.5 years).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease
• Actual Study Start Date: Jan 6, 2021
• Anticipated Primary Completion Date: Mar 7, 2025
• Anticipated Study Completion Date: Nov 5, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-63733657 Participants will receive single dose of JNJ-63733657 low dose or high dose administered by intravenous (IV) infusion every 4 weeks.	Drug: JNJ-63733657; JNJ-63733657 low or high dose will be administered by IV infusion.
Placebo Comparator: Placebo Participants will receive single dose of matching placebo to JNJ-63733657 administered by IV infusion every 4 weeks.	Drug: Placebo; Placebo matching to JNJ-63733657 will be administered by IV infusion.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) [Baseline up to 4.5 years (End of treatment)]

   The linear combination of the ADAS Cog13 and ADCS ADL MCI that serves as a composite of cognition and function (overall clinical status) of the participant and score range from 0 to 134 with lower scores indicating worse performance. The iADRS will be a combination of ADAS Cog13 (score 0 to 85, higher scores indicate worse cognitive performance) and ADCS-ADL MCI (excluding item 3 for dressing, yielding a score 0 to 49, lower scores indicate worse daily function).

Secondary Outcome Measures

1. Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive subscale 13-item version (ADAS-Cog 13) Total Score [Baseline and up to 4.5 years (End of treatment)]

   ADAS-Cog11 consists of 11 tasks measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities. The modified ADAS-Cog 13 item scale includes all original ADAS-Cog items with the addition of a number cancellation task and a delayed free recall task, for a maximum total score of 85 points, with higher scores indicative of worse cognitive performance. Thus, a negative change from baseline represents improvement in cognition. Items are recorded on an electronic device which will provide the ADAS-Cog 13 total score.

2. Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL MCI) [Baseline and up to 4.5 years (End of treatment)]

   ADCS-ADL MCI is a functional measure based on information provided by the study partner (informant) that describes the performance of participants in several ADLs. It assesses 17 instrumental activities of daily living (higher level daily functions) and one basic daily function (dressing). Total score ranges from 0 to 53 with higher scores indicating less impairment.

3. Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score [Baseline and up to 4.5 years (End of treatment)]

   The RBANS includes 12 subtests that are divided into 5 RBANS indices: 1-Immediate memory (List learning and story memory); 2-Visuospatial/constructional (figure copy and line orientation); 3-Language (picture naming and semantic fluency); 4-Attention (digit span and coding); 5-Delayed memory (list recall, list recognition, story memory, and figure recall) will be reported. Index scores are expressed as an age-adjusted standard score with a normal mean of 100 and an SD of 15. The sum of Index Scores is the sum of the 5 index scores, and the Sum of Index Scores is converted to an RBANS Total Scale Index Score via a mapping table. RBANS Total Scale Index Score is a norm-based t-score, based on a distribution with a mean of 100 and standard deviation (SD) of 15. Higher scores on each sub measure and index indicate better performance.

4. Change From Baseline in RBANS Indices [Baseline and up to 4.5 years (End of treatment)]

   Change from baseline in RBANS indices will be assessed. The RBANS includes 12 subtests that are divided into 5 RBANS indices: 1-Immediate memory (List learning and story memory); 2-Visuospatial/constructional (figure copy and line orientation); 3-Language (picture naming and semantic fluency); 4-Attention (digit span and coding); 5-Delayed memory (list recall, list recognition, story memory, and figure recall) will be reported.

5. Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) [Baseline and up to 4.5 years (End of treatment)]

   CDR is a global clinical staging instrument that includes 3 cognitive and 3 functional ratings, including: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care based on the CDR interview. The CDR is scored 2 ways yielding a global CDR score (CDR GS, derived from an algorithm including categorical scoring of 0, 0.5, 1, 2, and 3), as well as CDR-Sum of Boxes (CDR-SB, the continuous sum of 6 domains, up to a total score of 18, with higher scores representing worse disease state). The Sum of boxes and global score is calculated from the overall CDR.

6. Change from Baseline in Neuropsychiatric Inventory (NPI) [Baseline and up to 4.5 years (End of treatment)]

   The NPI is a measure of psychobehavioral disturbances, assessing the frequency and severity of disturbances in 12 domains. Frequency for each domain is rated on a 4 point scale (from 1=rarely to 4=very often) and severity on a 3 point scale (from 1=mild to 3=severe), with the score for each domain being the product of the frequency and severity scores, such that each domain is scored from 1 to 12. The NPI total score is the sum of the 12 domain scores, ranging from 0 (best) to 144 (worst).

7. Percentage of Participants Progressing From Clinical Dementia Rating- Global Score (CDR-GS) 0 to 0.5 or Higher, 0.5 to 1 or Higher, 1 to 2 or Higher, from Baseline to Post-baseline [Baseline and up to 4.5 years (End of treatment)]

   The CDR is a subjectively rated outcome measure that serves as a global clinical staging instrument that includes 3 cognitive and 3 functional ratings, including: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the CDR interview. The CDR is scored 2 ways yielding a global CDR score (CDR GS, derived from an algorithm developed by the Knight Alzheimer Disease Research Center at Washington University School of Medicine in St. Louis, Missouri, US, and including categorical scoring of 0= cognitively unimpaired, 0.5= mild cognitive impairment, 1= mild dementia, 2= moderate dementia, and 3= severe dementia), as well as CDR-Sum of Boxes (CDR-SB, the continuous sum of 6 domains, up to a total score of 18, with higher scores representing worse disease state).

8. Change From Baseline in Brain tau Burden as Measured by tau PET [Baseline and up to 4.5 years (End of treatment)]

   Change from baseline in brain tau burden, as measured by tau positron emission tomography (PET) will be assessed.

9. Change From Baseline in Cerebrospinal Fluid (CSF) concentrations of Total, Free, and Bound p217+tau Fragments [Baseline and up to 4.5 years (End of treatment)]

   Change from baseline in CSF concentrations of total, free, and bound p217+tau (phosphorylated tau) fragments will be assessed.

10. CSF Concentrations of JNJ-63733657 [At Weeks 52, 104, 208 (End of Treatment)]

    CSF concentrations of JNJ-63733657 will be assessed.

11. Serum Concentrations of JNJ-63733657 [At Weeks 4, 8, 12, 16, 20, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232 (End of treatment)]

    Serum concentrations of JNJ-63733657 will be assessed.

12. Anti-Drug Antibody to JNJ-63733657 [Up to 245 Weeks (90 days [+-7 days] after last dose of study intervention)]

    Anti-drug antibody to JNJ-63733657 will be assessed.

13. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [Up to 245 Weeks]

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.

14. Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [Up to 245 Weeks]

    An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

15. Number of Participants with Electrocardiogram (ECG) Abnormalities [Up to 245 Weeks]

    Number of participants with ECG abnormalities will be reported.

16. Number of Participants with Clinical Laboratory Abnormalities [Baseline and up to 245 Weeks]

    Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.

17. Number of Participants with Physical and Neurological Examination Abnormalities [Up to 245 Weeks]

    Number of participants with physical (body weight, height) and neurological (evaluation of mental status, cranial nerves, motor ability [including strength, tone, and involuntary movements], coordination [including finger-to-nose, gait, and postural reflexes], and sensation [including proprioception, cold, light touch, and deep tendon reflexes]) examination abnormalities will be reported.

18. Percentage of Participants with Vital Sign Abnormalities [Up to 245 Weeks]

    Percentage of participants with vital sign abnormalities (temperature, pulse rate, systolic blood pressure [BP], diastolic BP) will be reported.

19. Changes From Baseline in Brain Magnetic Resonance Imaging (MRI) Safety Findings [Baseline and Up to 4.5 years (End of treatment)]

    Changes from baseline in brain MRI safety findings (brain tumors, aneurysm or atrioventricular malformations, territorial stroke (excluding smaller watershed strokes), recent hemorrhage (parenchymal or subdural), or obstructive hydrocephalus) will be assessed.

20. Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) score [Baseline and Up to 245 Weeks]

    C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors . Total score ranges from 1 to 10, a score of 0 will be assigned (0="no event that can be assessed on the basis of C-SSRS"). Higher scores indicate greater severity. The maximum score assigned for each participant will also be summarized into one of three broad categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5), suicidal behavior (6 to 10).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Early Alzheimer's disease (AD): Gradual and progressive subjective decline in the participant's cognition over at least the past 6 months, as reported by the participant and informant (study partner) and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 and memory box score greater than or equal to (>=) 0.5 at screening

• Participants must have positive tau PET results

• Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening

• Have a designated study partner who has adequate literacy to participate and be judged to have high likelihood of completing the study with the participant

• Male participants must agree not to donate sperm for the purpose of reproduction during the study and up to 16 weeks after receiving the last dose of study intervention

Exclusion Criteria:

• Participants with CDR GS >=2 at predose baseline Clinical Dementia Rating (CDR) administration

• Participants who fulfill diagnostic criteria for Mild Cognitive Impairment (MCI) or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (example, parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, (Et cetera[etc])

• Geriatric Depression Scale (GDS) 30 score greater than (>) 12

• Hachinski Ischemic Scale (HIS) >4

• Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 2 months; that is, doses of chronic medications that effect the CNS should be stable for at least 2 months before the start of screening. If a participant has recently stopped a chronic medication that effects the CNS, he or she must have discontinued treatment at least 2 months before the start of screening. Chronic use of benzodiazepines is not permitted

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Birmingham	Birmingham	Alabama	United States	35294
2	Dignity Health	Phoenix	Arizona	United States	85013
3	Banner Sun Health Research Institute	Sun City	Arizona	United States	85351
4	University of Arizona - Behavioral Neuroscience and Alzheimer's Clinic	Tucson	Arizona	United States	85724
5	Irvine Clinical Research	Irvine	California	United States	92614
6	University of California San Diego Medical Center	La Jolla	California	United States	92037
7	Pharmacology Research Institute	Los Alamitos	California	United States	90720
8	University of California - Los Angeles	Los Angeles	California	United States	90095
9	Stanford University Medical Center	Palo Alto	California	United States	94304
10	Pacific Research Network Prn	San Diego	California	United States	92103
11	Syrentis Clinical Research	Santa Ana	California	United States	92705
12	Yale University School Of Medicine	New Haven	Connecticut	United States	06510
13	Georgetown University Hospital	Washington	District of Columbia	United States	20057
14	JEM Research, LLC	Atlantis	Florida	United States	33462
15	Brain Matters Research	Delray Beach	Florida	United States	33445
16	Neuropsychiatric Research Center of SWFL	Fort Myers	Florida	United States	33912
17	Clinical NeuroScience Solutions, Inc	Jacksonville	Florida	United States	32256
18	Alphab Global Research	Jupiter	Florida	United States	33458
19	Charter Research	Lady Lake	Florida	United States	32159
20	ClinCloud Clinical Research	Maitland	Florida	United States	32751
21	Merritt Island Medical Research, LLC	Merritt Island	Florida	United States	32952
22	University of Miami Miller School of Medicine	Miami	Florida	United States	33136
23	Miami Jewish Health System	Miami	Florida	United States	33137
24	Collier Neurologic Specialists LLC	Naples	Florida	United States	34105
25	Renstar Medical Research	Ocala	Florida	United States	34470
26	Sensible Healthcare	Ocoee	Florida	United States	34761
27	K2 Medical Research	Orlando	Florida	United States	32789
28	Axiom Clinical Research of Florida	Tampa	Florida	United States	33609
29	Stedman Clinical Trials	Tampa	Florida	United States	33613
30	University of South Florida - Health Byrd Alzheimer Institute	Tampa	Florida	United States	33613
31	ClinCloud Clinical Research	Viera	Florida	United States	32904
32	Alzheimers Research and Treatment Center	Wellington	Florida	United States	33414
33	Palm Beach Neurology and Premier Research Institute	West Palm Beach	Florida	United States	33407
34	Conquest Research	Winter Park	Florida	United States	32789
35	Emory Clinic	Atlanta	Georgia	United States	30329
36	Sandhill Research	Decatur	Georgia	United States	30030
37	Rush University Medical Center	Chicago	Illinois	United States	60612
38	Great Lakes Clinical Trials	Chicago	Illinois	United States	60640
39	Alexian Brothers Medical Center - Neuroscience Research Institute	Elk Grove Village	Illinois	United States	60007
40	Consultants In Neurology LTD	Northbrook	Illinois	United States	60062
41	Indiana University	Indianapolis	Indiana	United States	46202
42	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
43	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
44	Anil Nair dba Alzheimer's Disease Center	Braintree	Massachusetts	United States	02184
45	Hattiesburg Clinic	Hattiesburg	Mississippi	United States	39401
46	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
47	NeuroCognitive Institute	Mount Arlington	New Jersey	United States	07856
48	Princeton Medical Institute	Princeton	New Jersey	United States	08540
49	Advanced Memory Research Institute of NJ	Toms River	New Jersey	United States	08755
50	Albany Medical College	Albany	New York	United States	12208
51	Neurological Associates of Albany, PC	Albany	New York	United States	12208
52	Clarity Clinical Research, LLC	East Syracuse	New York	United States	13057
53	New York University Medical Center	New York	New York	United States	10016
54	Columbia University Medical Center	New York	New York	United States	10032
55	Raleigh Neurology Associates	Raleigh	North Carolina	United States	27607
56	Wake Forest Health Sciences	Winston-Salem	North Carolina	United States	27157
57	Cleveland Clinic Lou Revo Center for Brain Health	Cleveland	Ohio	United States	44195
58	Wexner Medical Center at the Ohio State University	Columbus	Ohio	United States	43221
59	Keystone Clinical Studies, LLC	Plymouth Meeting	Pennsylvania	United States	19462
60	Abington Neurological Associates Ltd	Willow Grove	Pennsylvania	United States	19090
61	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island	United States	02914
62	Rhode Island Hospital	Providence	Rhode Island	United States	02903
63	Brown University School of Medicine	Providence	Rhode Island	United States	02906
64	Clinical NeuroScience Solutions, Inc	Memphis	Tennessee	United States	38119
65	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77054
66	UT Health Science Center at San Antonio	San Antonio	Texas	United States	78229
67	Memory Clinic Inc	Bennington	Vermont	United States	05201
68	University of Virginia	Charlottesville	Virginia	United States	22903
69	Royal Adelaide Hospital	Adelaide		Australia	5000
70	Box Hill Hospital	Box Hill		Australia	3128
71	Austin Health	Ivanhoe		Australia	3079
72	HammondCare Neurodegenerative Clinical Trials - VIC	Malvern		Australia	3144
73	Alfred Health	Melbourne		Australia	3004
74	Australian Alzheimer's Research Foundation Incorporated	Nedlands		Australia	6009
75	Neuro Trials Victoria	Noble Park		Australia	3174
76	Royal Melbourne Hospital	Parkville		Australia	3050
77	AZ St.-Jan Brugge-Oostende AV	Brugge		Belgium	8000
78	UCL Hopital Saint-Luc	Brussels		Belgium	1200
79	UZ Antwerpen	Edegem		Belgium	2650
80	Universitair Ziekenhuis Gent	Gent		Belgium	9000
81	Jessa Ziekenhuis	Hasselt		Belgium	3500
82	UZ Brussel	Jette		Belgium	1090
83	UZ Leuven	Leuven		Belgium	3000
84	GIGA Centre de Recherches du Cyclotron, Université de Liège	Liège		Belgium	4000
85	Algemeen Ziekenhuis Delta	Roeselare		Belgium	8800
86	JBN Medical Diagnostics Services, Inc.	Burlington	Ontario	Canada	L7M 4Y1
87	Parkwood Institute	London	Ontario	Canada	N65J1
88	Kawartha Centre - Redefining Healthy Aging	Peterborough	Ontario	Canada	K9H 2P4
89	UHN-Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
90	McGill University	Montreal	Quebec	Canada	H3A 2B4
91	Toronto Memory Program (Neurology Research Inc.)	Toronto		Canada	M3B 257
92	Hôpital Pellegrin CHU Bordeaux	Bordeaux		France	33076
93	Hopital Roger Salengro - CHU Lille	Lille		France	59037
94	CHU Nantes - Hopital Nord Laënnec	Nantes		France	44093
95	Hopital Lariboisiere-Fernand Widal	Paris		France	75010
96	Hopital Pitie Salpetriere	Paris		France	75013
97	Chu Rennes - Hopital Pontchaillou	Rennes		France	35009
98	Hopital Charles Nicolle	Rouen		France	76031
99	CHU Toulouse - Hôpital La Grave	Toulouse		France	31059
100	Hôpital Bretonneau	Tours		France	37000
101	Takeda General Hospital	Aizuwakamatsu		Japan	965-8585
102	Inage Neurology and Memory Clinic	Chiba-shi		Japan	263-0043
103	Kawashima Neurology Clinic	Fujisawa-shi		Japan	251-0038
104	Fukuoka University Hospital	Fukuoka		Japan	814-0180
105	Keikokai P-One Clinic	Hachioji		Japan	192-0071
106	Himeji Central Hospital Clinic	Himeji-city, Hyogo		Japan	672-8043
107	Shonan Kamakura General Hospital	Kamakura-shi		Japan	247-8533
108	National Hospital Organization Hizen Psychiatric Center	Kanzaki-gun		Japan	842-0192
109	Koukankai Koukan Clinic	Kawasaki-shi		Japan	210-0852
110	Kobe City Medical Center General Hospital	Kobe-shi		Japan	650-0047
111	Rijikai Medical Corporation Katayama Medical Clinic	Kurashiki-shi		Japan	7100813
112	Kurume University Hospital	Kurume		Japan	830-0011
113	Rakuwakai Otowa Rehabilitation Hospital	Kyoto-shi		Japan	607-8113
114	Rakuwakai Otowa Hospital	Kyoto		Japan	607-8062
115	Saiseikai Narashino Hospital	Narashino		Japan	275-0006
116	National Center For Geriatrics And Gerontology	Obu-shi		Japan	474-8511
117	Clinical Research Hospital Tokyo	Shinjuku-ku		Japan	162-0053
118	Shizuoka City Shimizu Hospital	Shizuoka-shi		Japan	424-8636
119	Tokyo Medical University Hospital	Tokyo		Japan	160-0023
120	Tokyo Metropolitan Geriatric Hospital	Tokyo		Japan	173-0015
121	Jinsenkai MI Clinic	Toyonaka-shi		Japan	560-0004
122	Nagomi Clinic	Toyonaka-shi		Japan	560-0004
123	Yokohama Brain and Spine Center	Yokohama-shi		Japan	235-0012
124	BRC - Amsterdam	Amsterdam		Netherlands	1081 GN
125	BRC - Den Bosch	Den Bosch		Netherlands	5223 LA
126	QPS Netherlands	Leeuwarden		Netherlands	8934AD
127	Erasmus MC	Rotterdam		Netherlands	3015GD
128	BRC - Zwolle	Zwolle		Netherlands	8052 AZ
129	CAE Oroitu	Algorta - Getxo		Spain	48993
130	Hosp. Del Mar	Barcelona		Spain	08003
131	Fundacio ACE	Barcelona		Spain	08028
132	Hosp. de La Santa Creu I Sant Pau	Barcelona		Spain	08041
133	Idc Salud Hosp. Gral. de Catalunya	Barcelona		Spain	08195
134	Fund. Pasqual Maragall	Barcelona		Spain	8005
135	Hosp. Univ. Santa Maria	Lleida		Spain	25198
136	Hosp. Clinico San Carlos	Madrid		Spain	28040
137	Hosp. Mutua Terrassa	Terrassa		Spain	08221
138	Hosp. Univ. I Politecni La Fe	Valencia		Spain	46026
139	Länssjukhuset Ryhov	Jönköping		Sweden	55185
140	Karolinska Universitetssjukhuset	Stockholm		Sweden	14186
141	Royal United Hospital	Bath		United Kingdom	BA1 3NG
142	Fulbourne Hospital	Cambridge		United Kingdom	CB21 5EF
143	Charing Cross Hospital	London		United Kingdom	W6 8RF
144	The National Hospital for Neurology and Neurosurgery Centre	London		United Kingdom	WC1N 3BG

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT04619420
• Other Study ID Numbers: CR108832; 2020-000116-30; 63733657ALZ2002
• First Posted: Nov 6, 2020
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Alzheimer Disease; Cognitive Dysfunction

Study Results

No Results Posted as of Aug 18, 2022