A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease
NCT ID: NCT05063539
Last Updated: 2025-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
327 participants
INTERVENTIONAL
2021-09-16
2025-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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0.75 Milligram (mg) LY3372689
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks
LY3372689
given orally
3 mg LY3372689
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
LY3372689
given orally
Placebo
Participants received placebo administered orally once daily for up to 124 weeks.
Placebo
given orally
Interventions
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LY3372689
given orally
LY3372689
given orally
Placebo
given orally
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Have known allergies to LY3372689, related compounds, or any components of the formulations
60 Years
85 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Sharp Mesa Vista Hospital
San Diego, California, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
Irvine Clinical Research
Irvine, California, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
VIN-Julie Schwartzbard
Aventura, Florida, United States
Neurology Offices of South Florida
Boca Raton, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
K2 Medical Research
Maitland, Florida, United States
ClinCloud - Viera
Melbourne, Florida, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States
VIN-Andrew Lerman
Miami, Florida, United States
IMIC, Inc.
Miami, Florida, United States
VIN-Victor Faradji
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
VIN- Margarita Almeida El-Ramey
Pembroke Pines, Florida, United States
Brain Matters Research
Stuart, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States
Boston Center for Memory
Newton, Massachusetts, United States
Donald S. Marks M.D., P.C.
Plymouth, Massachusetts, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States
University at Buffalo - UBMD Neurology
Buffalo, New York, United States
Abington Neurological Associates, Ltd.
Abington, Pennsylvania, United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Kerwin Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The Memory Clinic
Bennington, Vermont, United States
Central Coast Neurosciences Research (Tumbi Umbi)
Central Coast, New South Wales, Australia
St Vincent's Hospital
Sydney, New South Wales, Australia
HammondCare Greenwich Hospital
Sydney, New South Wales, Australia
Hornsby Ku-Ring-Gai Hospital
Sydney, New South Wales, Australia
KARA Institute for Neurological Diseases
Sydney, New South Wales, Australia
Private Practice - Dr PL Morris
Southport, Queensland, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
NeuroCentrix
Carlton, Victoria, Australia
Delmont Private Hospital
Glen Iris, Victoria, Australia
HammondCare
Malvern, Victoria, Australia
Bruyère Research Institute
Ottawa, Ontario, Canada
Clinique de la Mémoire de l'Outaouais
Ottawa, Ontario, Canada
Ottawa Memory Clinic
Ottawa, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
National Center for Geriatrics and Gerontology
Ōbu, Aichi-ken, Japan
Himeji Central Hospital Affiliated Clinic
Himeji, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Memory Clinic Toride
Toride, Ibaraki, Japan
Oita University Hospital
Yufu, Oita Prefecture, Japan
Katayama Medical Clinic
Kurashiki, Okayama-ken, Japan
Nozomi Memory Clinic
Mitaka-shi, Tokyo, Japan
Kikukawa Clinic
Nerima City, Tokyo, Japan
Memory Clinic Ochanomizu
Tokyo, , Japan
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Diamond Clinic
Krakow, Lesser Poland Voivodeship, Poland
Wroclawskie Centrum Alzheimerowskie
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship, Poland
Podlaskie Centrum Psychogeriatrii
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne SENIOR
Sopot, Pomeranian Voivodeship, Poland
Centrum Medyczne Euromedis
Szczecin, West Pomeranian Voivodeship, Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease
Other Identifiers
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I9X-MC-MTAE
Identifier Type: OTHER
Identifier Source: secondary_id
2021-000170-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-512295-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
18094
Identifier Type: -
Identifier Source: org_study_id
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