RecruitingNCT03507257

Longitudinal Early-onset Alzheimer's Disease Study Protocol

Sponsor

Indiana University

Enrollment

850 participants

Start Date

Apr 30, 2018

Study Type

OBSERVATIONAL

Conditions

Early-Onset Alzheimer Disease Alzheimer Disease Mild Cognitive Impairment

Summary

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants.

Eligibility

Min Age: 40 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying early-onset Alzheimer's disease in people who developed memory or thinking problems before age 65, to better understand how the disease progresses and how it differs from Alzheimer's that develops later in life. **You may be eligible if...** - You are between 40 and 64 years old - You have been diagnosed with mild cognitive impairment (early memory loss) or probable Alzheimer's disease, OR you are cognitively healthy and willing to serve as a comparison participant - You have a family member, friend, or caregiver who spends at least 10 hours per week with you and can report on your daily functioning - You speak English, Spanish, Dutch, or Swedish depending on your study site - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You are younger than 40 or older than 64 - You do not have a study partner who can provide information about your daily life - You are pregnant or breastfeeding - You are not fluent in one of the required languages for your study location Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFlortaucipir

All participants will receive a single bolus intravenous injection of approximately 10 mCi (+/- 10%, 20μg mass dose) of flortaucipir (18F-AV-1451). At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.

DRUGFlorbetaben

All participants will receive a single bolus intravenous injection of approximately 8 mCi +/- .8mCi of florbetaben (AV-45). At approximately 90-minutes (+/- 10 minutes) post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.

DRUGFluorodeoxyglucose

All participants will receive a single bolus intravenous injection of approximately 5 mCi (+/- 10%, 0.5 mCi) of fluorodeoxyglucose. At approximately 30 minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.

Locations(23)

Banner Sun Health Research Institute

Sun City, Arizona, United States

University of California, Los Angeles

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

University of California, San Francisco

San Francisco, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

Wien Center

Miami Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Washington University, St. Louis

St Louis, Missouri, United States

Columbia University

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Butler Hospital

Providence, Rhode Island, United States

Houston Methodist Hospital

Houston, Texas, United States

Fleni

Buenos Aires, Argentina

Amsterdam UMC

Amsterdam, Netherlands

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Lund University

Malmö, Sweden

University College London

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03507257

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