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A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05063539
Collaborator
(none)
330
Enrollment
71
Locations
3
Arms
32.9
Anticipated Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Based on a common closed study design. Participants final endpoint time will be between 76-124 weeks.Based on a common closed study design. Participants final endpoint time will be between 76-124 weeks.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Assessment of Safety, Tolerability, and Efficacy of LY3372689 in Early Symptomatic Alzheimer's Disease
Actual Study Start Date :
Sep 16, 2021
Anticipated Primary Completion Date :
May 16, 2024
Anticipated Study Completion Date :
Jun 13, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3372689 High Dose

LY3372689 given orally

Drug: LY3372689
given orally
Experimental: LY3372689 Low Dose

LY3372689 given orally

Drug: LY3372689
given orally
Placebo Comparator: Placebo

Placebo given orally

Drug: Placebo
given orally

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS) [Baseline, 76 to 124 Weeks]

    Change from Baseline to End Time Point in iADRS will be measured in participants with early symptomatic Alzheimer's Disease (AD) with demonstrated presence of moderate levels of tau pathology

Secondary Outcome Measures

  1. Change from Baseline to End Time Point in iADRS [Baseline, 76 to 124 Weeks]

    Change from baseline to end point time in iADRS will be measured in the full study population (moderate + high levels of tau pathology) with early symptomatic AD

  2. Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [Baseline, 76 to 124 Weeks]

    Change From Baseline to End Time Point in CDR-SB

  3. Change from Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [Baseline, 76 to 124 Weeks]

    Change from Baseline to End Time Point in ADAS-Cog13

  4. Change from Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) [Baseline, 76 to 124 Weeks]

    Change from Baseline to End Time Point in ADCS-iADL

  5. Change from Baseline to End Time Point in Mini Mental State Examination (MMSE) [Baseline, 76 to 124 Weeks]

    Change from Baseline to End Time Point in MMSE

  6. Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan [Baseline, 76 to 124 Weeks]

    Change from Baseline to End Time Point in Brain Tau Deposition as Measured by Flortaucipir F18 PET scan

  7. Change from Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures [Baseline, 76 to 124 Weeks]

    Change from Baseline to End Time Point in Volumetric MRI Measures

  8. Pharmacokinetics (PK) Plasma Concentration of LY3372689 [Up to 124 Weeks]

    PK Plasma Concentration of LY3372689

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months

  • MMSE score of 22 to 30 (inclusive) at baseline

  • CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5.

  • Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria

  • Have a study partner who will provide written informed consent to participate

Exclusion Criteria:

  • Contraindication to MRI or PET scans

  • Have known allergies to LY3372689, related compounds, or any components of the formulations

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hope Clinical Research, Inc. Canoga Park California United States 91303
2 Neuro-Pain Medical Center Fresno California United States 93710
3 Irvine Clinical Research Center Irvine California United States 92614
4 Sharp Mesa Vista Hospital San Diego California United States 92123
5 Institute for Neurodegenerative Disorders New Haven Connecticut United States 06510
6 JEM Research Institute Atlantis Florida United States 33462
7 VIN-Julie Schwartzbard Aventura Florida United States 33180
8 Neurology Offices of South Florida Boca Raton Florida United States 33428
9 Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida United States 33912
10 Charter Research Lady Lake Florida United States 32159
11 K2 Medical Research Maitland Florida United States 32751
12 ClinCloud - Viera Melbourne Florida United States 32940
13 Merritt Island Medical Research, LLC Merritt Island Florida United States 32952
14 Visionary Investigators Network Miami Florida United States 33133
15 VIN-Victor Faradji Miami Florida United States 33176
16 Suncoast Clinical Research New Port Richey Florida United States 34652
17 Renstar Medical Research Ocala Florida United States 34470
18 IMIC, Inc. Palmetto Bay Florida United States 33157
19 VIN- Margarita Almeida El-Ramey Pembroke Pines Florida United States 33026
20 Brain Matters Research Stuart Florida United States 34997
21 Josephson Wallack Munshower Neurology, PC Indianapolis Indiana United States 46256
22 Eastern Maine Medical Center Bangor Maine United States 04401
23 Boston Center for Memory Newton Massachusetts United States 02459
24 Donald S. Marks M.D., P.C. Plymouth Massachusetts United States 02360
25 MedVadis Research Corporation Waltham Massachusetts United States 02451
26 Adams Clinical Watertown Massachusetts United States 02472
27 The Cognitive and Research Center of New Jersey Springfield New Jersey United States 07081
28 Advanced Memory Research Institute of New Jersey Toms River New Jersey United States 08755
29 University at Buffalo - UBMD Neurology Buffalo New York United States 14203
30 NYU Langone Health New York New York United States 10016
31 Abington Neurological Associates, Ltd. Abington Pennsylvania United States 19001
32 Keystone Clinical Studies Plymouth Meeting Pennsylvania United States 19462
33 Rhode Island Mood & Memory Research Institute East Providence Rhode Island United States 02914
34 Kerwin Medical Center Dallas Texas United States 75231
35 The University of Texas Health Science Center at Houston Houston Texas United States 77054
36 The Memory Clinic Bennington Vermont United States 05201-9810
37 St Vincent's Hospital Sydney Sydney New South Wales Australia 2010
38 HammondCare Sydney New South Wales Australia 2065
39 Hornsby Ku-Ring-Gai Hospital Sydney New South Wales Australia 2077
40 KARA Institute for Neurological Diseases Sydney New South Wales Australia 2113
41 Central Coast Neurosciences Research (Tumbi Umbi) Tumbi Umbi New South Wales Australia 2261
42 The Prince Charles Hospital Brisbane Queensland Australia 4032
43 Private Practice - Dr PL Morris Southport Queensland Australia 4215
44 The Queen Elizabeth Hospital Woodville South Australia Australia 5011
45 Box Hill Hospital Outpatients Box Hill Victoria Australia 3128
46 Delmont Consulting Suites Glen Iris Victoria Australia 3146
47 HammondCare Malvern Victoria Australia 3144
48 NeuroCentrix Noble Park Victoria Australia 3174
49 Bruyère Research Institute Ottawa Ontario Canada K1N 5C8
50 Ottawa Memory Clinic Ottawa Ontario Canada K1Z 1G3
51 Toronto Memory Program Toronto Ontario Canada M3B 2S7
52 Clinique de la Mémoire de l'Outaouais Gatineau Quebec Canada J8T 8J1
53 Diex Recherche Sherbrooke Inc. Sherbrooke Quebec Canada J1L 0H8
54 National Center for Geriatrics and Gerontology Obu City Aichi Japan 4748511
55 Himeji Central Hospital Clinic Himeji Hyogo Japan 672-8043
56 Kobe City Medical Center General Hospital Kobe Hyogo Japan 650-0047
57 Memory Clinic Toride Toride Ibaraki Japan 302-0004
58 Katayama Medical Clinic Kurashiki Okayama Japan 710-0813
59 Nozomi Memory Clinic Mitaka-shi Tokyo Japan 181-0013
60 Kikukawa Clinic Nerima Tokyo Japan 179-0072
61 Memory Clinic Ochanomizu Tokyo Japan 113-0034
62 Oita University Hospital Yufu Japan 879-5503
63 Wroclawskie Centrum Alzheimerowskie Wroclaw Dolnośląskie Poland 53-659
64 Centrum Medyczne NEUROMED Bydgoszcz Kujawsko-pomorskie Poland 85-163
65 Centrum Medyczne NeuroProtect Warszawa Mazowieckie Poland 01-684
66 Diamond Clinic Krakow Małopolskie Poland 31-559
67 Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie Poland 80-546
68 Centrum Medyczne SENIOR Sopot Pomorskie Poland 81-855
69 Nzoz Neuro-Kard Ilkowski i Partnerzy SPL Poznan Wielkopolskie Poland 61-853
70 Centrum Medyczne Euromedis Szczecin Zachodniopomorskie Poland 70-111
71 Podlaskie Centrum Psychogeriatrii Białystok Poland 15-756

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)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05063539
Other Study ID Numbers:
  • 18094
  • I9X-MC-MTAE
  • 2021-000170-29
First Posted:
Oct 1, 2021
Last Update Posted:
Aug 9, 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
Keywords provided by Eli Lilly and Company
Dementia
Mild Cognitive Impairment
Prodromal Alzheimer's Disease
Tauopathy
Tau
OGA Inhibitor
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Aug 9, 2022