A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease
Assessment of Safety, Tolerability, and Efficacy of LY3372689 in Early Symptomatic Alzheimer's Disease
4 other identifiers
interventional
327
5 countries
69
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 alzheimer-disease
Started Sep 2021
Typical duration for phase_2 alzheimer-disease
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2021
CompletedStudy Start
First participant enrolled
September 16, 2021
CompletedFirst Posted
Study publicly available on registry
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2025
CompletedResults Posted
Study results publicly available
July 28, 2025
CompletedJuly 28, 2025
July 1, 2025
2.8 years
September 14, 2021
July 9, 2025
July 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
iADRS is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether LY3372689 slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) adjusted for age at baseline, AChEI/Memantine use at baseline, pooled investigator. Data presented are posterior mean with 95% credible interval.
Baseline, Week 100
Secondary Outcomes (14)
Change From Baseline to End Time Point in iADRS (Overall Population)
Baseline, Week 100
Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)
Baseline, Week 76
Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Overall Population)
Baseline, Week 76
Change From Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)
Baseline, Week 76
Change From Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)
Baseline, Week 76
- +9 more secondary outcomes
Study Arms (3)
0.75 Milligram (mg) LY3372689
EXPERIMENTALParticipants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks
3 mg LY3372689
EXPERIMENTALParticipants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
Placebo
PLACEBO COMPARATORParticipants received placebo administered orally once daily for up to 124 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
- MMSE score of 22 to 30 (inclusive) at screening
- 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
You may not qualify if:
- Contraindication to MRI or PET scans
- Have known allergies to LY3372689, related compounds, or any components of the formulations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Hope Clinical Research, Inc.
Canoga Park, California, 91303, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Irvine Clinical Research
Irvine, California, 92614, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
VIN-Julie Schwartzbard
Aventura, Florida, 33180, United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
K2 Medical Research
Maitland, Florida, 32751, United States
ClinCloud - Viera
Melbourne, Florida, 32940, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952, United States
VIN-Andrew Lerman
Miami, Florida, 33133, United States
IMIC, Inc.
Miami, Florida, 33176, United States
VIN-Victor Faradji
Miami, Florida, 33176, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
VIN- Margarita Almeida El-Ramey
Pembroke Pines, Florida, 33026, United States
Brain Matters Research
Stuart, Florida, 34997, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Donald S. Marks M.D., P.C.
Plymouth, Massachusetts, 02360, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Adams Clinical
Watertown, Massachusetts, 02472, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755, United States
University at Buffalo - UBMD Neurology
Buffalo, New York, 14203, United States
Abington Neurological Associates, Ltd.
Abington, Pennsylvania, 19001, United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Kerwin Medical Center
Dallas, Texas, 75231, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
The Memory Clinic
Bennington, Vermont, 05201-9810, United States
Central Coast Neurosciences Research (Tumbi Umbi)
Central Coast, New South Wales, 2261, Australia
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
HammondCare Greenwich Hospital
Sydney, New South Wales, 2065, Australia
Hornsby Ku-Ring-Gai Hospital
Sydney, New South Wales, 2077, Australia
KARA Institute for Neurological Diseases
Sydney, New South Wales, 2113, Australia
Private Practice - Dr PL Morris
Southport, Queensland, 4215, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
NeuroCentrix
Carlton, Victoria, 3053, Australia
Delmont Private Hospital
Glen Iris, Victoria, 3146, Australia
HammondCare
Malvern, Victoria, 3144, Australia
Bruyère Research Institute
Ottawa, Ontario, K1N 5C8, Canada
Clinique de la Mémoire de l'Outaouais
Ottawa, Ontario, K1Z 1G3, Canada
Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
National Center for Geriatrics and Gerontology
Ōbu, Aichi-ken, 4748511, Japan
Himeji Central Hospital Affiliated Clinic
Himeji, Hyōgo, 672-8043, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Memory Clinic Toride
Toride, Ibaraki, 302-0004, Japan
Oita University Hospital
Yufu, Oita Prefecture, 879-5593, Japan
Katayama Medical Clinic
Kurashiki, Okayama-ken, 710-0813, Japan
Nozomi Memory Clinic
Mitaka-shi, Tokyo, 181-0013, Japan
Kikukawa Clinic
Nerima City, Tokyo, 179-0072, Japan
Memory Clinic Ochanomizu
Tokyo, 113-0034, Japan
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
Poznan, Greater Poland Voivodeship, 61-853, Poland
Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland
Diamond Clinic
Krakow, Lesser Poland Voivodeship, 31-559, Poland
Wroclawskie Centrum Alzheimerowskie
Wroclaw, Lower Silesian Voivodeship, 53-203, Poland
Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship, 01-684, Poland
Podlaskie Centrum Psychogeriatrii
Bialystok, Podlaskie Voivodeship, 15-756, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne SENIOR
Sopot, Pomeranian Voivodeship, 81-855, Poland
Centrum Medyczne Euromedis
Szczecin, West Pomeranian Voivodeship, 70-111, Poland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2021
First Posted
October 1, 2021
Study Start
September 16, 2021
Primary Completion
July 9, 2024
Study Completion
May 22, 2025
Last Updated
July 28, 2025
Results First Posted
July 28, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.