A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia

NCT ID: NCT02791191

Last Updated: 2021-04-19

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2018-07-02

Brief Summary

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The main purpose of this study is to evaluate the safety and the effect on brain tau of the study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dose 1 LY3202626

3 mg LY3202626 given orally once daily for 52 weeks.

Group Type EXPERIMENTAL

LY3202626

Intervention Type DRUG

Administered orally

Dose 2 LY3202626

12 mg LY3202626 given orally once daily for 52 weeks.

Group Type EXPERIMENTAL

LY3202626

Intervention Type DRUG

Administered orally

Placebo

Placebo given orally once daily for 52 weeks.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Administered orally

Interventions

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LY3202626

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Present with mild AD dementia based on the National Institute on Aging (NIA) and the Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified clinician approved by the Sponsor or designee.
* Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.
* Has a florbetapir PET scan consistent with the presence of amyloid pathology at screening.

Exclusion Criteria

* Significant neurological disease affecting the central nervous system (CNS), other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
* Ocular pathology that significantly limits ability to reliably evaluate vision or the retina.
* Use of strong inducers of cytochrome P450 3A (CYP3A).
* Sensitivity to florbetapir or ¹⁸F-AV-1451.
* Contraindication to MRI or PET or poor venous access for blood draws.
Minimum Eligible Age

55 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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Irvine Clinical Research Center

Irvine, California, United States

Site Status

Sutter Medical Group

Sacramento, California, United States

Site Status

Pacific Research Network Inc

San Diego, California, United States

Site Status

Sharp Mesa Vista Hospital

San Diego, California, United States

Site Status

Ray Dolby Brain Health Center/Sutter Health/CPMC

San Francisco, California, United States

Site Status

Syrentis Clinical Research

Santa Ana, California, United States

Site Status

North Bay Neuroscience Institute

Sebastopol, California, United States

Site Status

New England Institute for Clinical Research

Stamford, Connecticut, United States

Site Status

Christiana Care Health Service

Wilmington, Delaware, United States

Site Status

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, United States

Site Status

Compass Research

Melbourne, Florida, United States

Site Status

Florida International Research Center

Miami, Florida, United States

Site Status

New Horizon Research Center

Miami, Florida, United States

Site Status

The Neurology Research Group, LLC

Miami, Florida, United States

Site Status

Suncoast Clinical Research

New Port Richey, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Sensible Healthcare

Ocoee, Florida, United States

Site Status

Meridien Research

Spring Hill, Florida, United States

Site Status

Axiom Research

Tampa, Florida, United States

Site Status

United Osteoporosis Center

Gainesville, Georgia, United States

Site Status

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

Site Status

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

Cotton O'Neil Clinic

Topeka, Kansas, United States

Site Status

Heartland Research Associates

Wichita, Kansas, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Boston Center for Memory

Newton, Massachusetts, United States

Site Status

Missouri Memory Center

Bolivar, Missouri, United States

Site Status

Clinical Research Professionals

Chesterfield, Missouri, United States

Site Status

Millenium Psychiatric Associates LLC

Creve Coeur, Missouri, United States

Site Status

St Lukes Hospital

Kansas City, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status

Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, United States

Site Status

Pyramid Clinical Research

Monroe, New Jersey, United States

Site Status

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, United States

Site Status

Bio Behavioral Health

Toms River, New Jersey, United States

Site Status

Albany Medical College

Albany, New York, United States

Site Status

Dent Neurological Institute

Amherst, New York, United States

Site Status

Valley Medical Primary Care

Centerville, Ohio, United States

Site Status

University of Cincinnati Health Neurology

Dayton, Ohio, United States

Site Status

Neurology Diagnostics, Inc.

Dayton, Ohio, United States

Site Status

Insight Clinical Trials

Shaker Heights, Ohio, United States

Site Status

Abington Neurological Associates

Abington, Pennsylvania, United States

Site Status

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Site Status

Clinical Trial Center, LLC, Psychiatry

Jenkintown, Pennsylvania, United States

Site Status

Clinical Trials of South Carolina

Charleston, South Carolina, United States

Site Status

Baylor AT&T Memory Center

Dallas, Texas, United States

Site Status

Nantz National Alzheimer Center

Houston, Texas, United States

Site Status

University of Texas Health Services Center - Houston

Houston, Texas, United States

Site Status

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Box Hill, , Australia

Site Status

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Chermside, , Australia

Site Status

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Darlinghurst, , Australia

Site Status

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Erina, , Australia

Site Status

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Glen Iris, , Australia

Site Status

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Heidelberg, , Australia

Site Status

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Herston, , Australia

Site Status

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Nedlands, , Australia

Site Status

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Parkville, , Australia

Site Status

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West Perth, , Australia

Site Status

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Gatineau, , Canada

Site Status

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Ottawa, , Canada

Site Status

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Verdun, , Canada

Site Status

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Akashi, , Japan

Site Status

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Hachiōji, , Japan

Site Status

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Ikeda, , Japan

Site Status

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Kasukabe-shi, , Japan

Site Status

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Kyoto, , Japan

Site Status

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Nagoya, , Japan

Site Status

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Nerima-ku, , Japan

Site Status

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Osaka, , Japan

Site Status

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Osaka, , Japan

Site Status

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Setagaya-ku, , Japan

Site Status

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Takamatsu, , Japan

Site Status

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Tokyo, , Japan

Site Status

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Wako, , Japan

Site Status

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Yokosuka-shi, , Japan

Site Status

Countries

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United States Australia Canada Japan

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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http://www.lillytrialguide.com/en-US/studies/mild-alzheimer's%20disease/LLCF#?postal=

Click here for more information about this study: A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia (NAVIGATE-AD)

Other Identifiers

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I7X-MC-LLCF

Identifier Type: OTHER

Identifier Source: secondary_id

16223

Identifier Type: -

Identifier Source: org_study_id

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