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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-16

Study Completion Date

2025-05-22

Brief Summary

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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

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Based on a common closed study design. Participants final endpoint time will be between 76-124 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Group Type EXPERIMENTAL

LY3372689

Intervention Type DRUG

given orally

3 mg LY3372689

Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.

Group Type EXPERIMENTAL

LY3372689

Intervention Type DRUG

given orally

Placebo

Participants received placebo administered orally once daily for up to 124 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

given orally

Interventions

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LY3372689

given orally

Intervention Type DRUG

LY3372689

given orally

Intervention Type DRUG

Placebo

given orally

Intervention Type DRUG

Eligibility Criteria

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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 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

* Contraindication to MRI or PET scans
* Have known allergies to LY3372689, related compounds, or any components of the formulations
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Hope Clinical Research, Inc.

Canoga Park, California, United States

Site Status

Neuro-Pain Medical Center

Fresno, California, United States

Site Status

Irvine Clinical Research

Irvine, California, United States

Site Status

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Site Status

JEM Research Institute

Atlantis, Florida, United States

Site Status

VIN-Julie Schwartzbard

Aventura, Florida, United States

Site Status

Neurology Offices of South Florida

Boca Raton, Florida, United States

Site Status

Brain Matters Research

Delray Beach, Florida, United States

Site Status

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, United States

Site Status

K2 Medical Research

Maitland, Florida, United States

Site Status

ClinCloud - Viera

Melbourne, Florida, United States

Site Status

Merritt Island Medical Research, LLC

Merritt Island, Florida, United States

Site Status

VIN-Andrew Lerman

Miami, Florida, United States

Site Status

IMIC, Inc.

Miami, Florida, United States

Site Status

VIN-Victor Faradji

Miami, Florida, United States

Site Status

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

VIN- Margarita Almeida El-Ramey

Pembroke Pines, Florida, United States

Site Status

Brain Matters Research

Stuart, Florida, United States

Site Status

Charter Research - Lady Lake

The Villages, Florida, United States

Site Status

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, United States

Site Status

Boston Center for Memory

Newton, Massachusetts, United States

Site Status

Donald S. Marks M.D., P.C.

Plymouth, Massachusetts, United States

Site Status

MedVadis Research Corporation

Waltham, Massachusetts, United States

Site Status

Adams Clinical

Watertown, Massachusetts, United States

Site Status

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, United States

Site Status

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, United States

Site Status

University at Buffalo - UBMD Neurology

Buffalo, New York, United States

Site Status

Abington Neurological Associates, Ltd.

Abington, Pennsylvania, United States

Site Status

Keystone Clinical Studies

Plymouth Meeting, Pennsylvania, United States

Site Status

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States

Site Status

Kerwin Medical Center

Dallas, Texas, United States

Site Status

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

The Memory Clinic

Bennington, Vermont, United States

Site Status

Central Coast Neurosciences Research (Tumbi Umbi)

Central Coast, New South Wales, Australia

Site Status

St Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

HammondCare Greenwich Hospital

Sydney, New South Wales, Australia

Site Status

Hornsby Ku-Ring-Gai Hospital

Sydney, New South Wales, Australia

Site Status

KARA Institute for Neurological Diseases

Sydney, New South Wales, Australia

Site Status

Private Practice - Dr PL Morris

Southport, Queensland, Australia

Site Status

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

Site Status

Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

NeuroCentrix

Carlton, Victoria, Australia

Site Status

Delmont Private Hospital

Glen Iris, Victoria, Australia

Site Status

HammondCare

Malvern, Victoria, Australia

Site Status

Bruyère Research Institute

Ottawa, Ontario, Canada

Site Status

Clinique de la Mémoire de l'Outaouais

Ottawa, Ontario, Canada

Site Status

Ottawa Memory Clinic

Ottawa, Ontario, Canada

Site Status

Toronto Memory Program

Toronto, Ontario, Canada

Site Status

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Site Status

National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, Japan

Site Status

Himeji Central Hospital Affiliated Clinic

Himeji, Hyōgo, Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

Memory Clinic Toride

Toride, Ibaraki, Japan

Site Status

Oita University Hospital

Yufu, Oita Prefecture, Japan

Site Status

Katayama Medical Clinic

Kurashiki, Okayama-ken, Japan

Site Status

Nozomi Memory Clinic

Mitaka-shi, Tokyo, Japan

Site Status

Kikukawa Clinic

Nerima City, Tokyo, Japan

Site Status

Memory Clinic Ochanomizu

Tokyo, , Japan

Site Status

Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

Poznan, Greater Poland Voivodeship, Poland

Site Status

Centrum Medyczne NEUROMED

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Diamond Clinic

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Wroclawskie Centrum Alzheimerowskie

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Centrum Medyczne NeuroProtect

Warsaw, Masovian Voivodeship, Poland

Site Status

Podlaskie Centrum Psychogeriatrii

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Centrum Medyczne SENIOR

Sopot, Pomeranian Voivodeship, Poland

Site Status

Centrum Medyczne Euromedis

Szczecin, West Pomeranian Voivodeship, Poland

Site Status

Countries

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United States Australia Canada Japan Poland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://trials.lillytrialguide.com/en-US/trial/6wDcj33niQMZDbeYm8iDfu

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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