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Longitudinal Study for Early-Onset Alzheimer's Disease

This observational study, called LEADS, is looking at how early-onset Alzheimer's disease (EOAD) and other early-onset memory problems progress over time. It involves people aged 40-64 who have mild cognitive impairment (MCI) due to Alzheimer's, probable Alzheimer's dementia, or no memory issues. You would receive injections of three different imaging drugs (Flortaucipir, Florbetaben, and Fluorodeoxyglucose) followed by brain scans. Researchers will track changes in your thinking and memory using tests like the ADAS-Cog13 over several years. The goal is to understand the disease better, not to test a new treatment. The study aims to enroll about 850 participants.

Study design
This is an observational study, meaning it watches how the disease progresses without testing a specific treatment. It plans to enroll about 850 participants.
What's involved
You would have clinical and cognitive assessments, biomarker and genetic tests, and brain scans (PET and MRI). Cognitively impaired participants will be in the study for 48+ months, and cognitively normal participants for 24+ months.
Compensation
Not stated in the trial record.
Follow-up
Cognitively impaired participants will be followed for at least 48 months, and cognitively normal participants for at least 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03507257

Longitudinal Early-onset Alzheimer's Disease Study Protocol

Active, Not Recruiting
Not specifiedAges 40–64Observational
Indiana University
~850 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:FlortaucipirFlorbetabenFluorodeoxyglucose

At a glance

Recruiting sites
0 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13)
Measured over Month 0, Month 12, Month 24, Month 36 (EOAD/EOnonAD only) and Month 48 (EOAD/EOnonAD only)

Conditions

Early Onset Alzheimer Disease
Alzheimer Disease
Mild Cognitive Impairment

Explore related trials

Alzheimer's DiseaseCognitively NormalMild cognitive disorder

Where it's being run

23 sites across 20 states
California3
Florida2
Arizona1
District of Columbia1
Georgia1
Illinois1
Indiana1
Maryland1

Study leadership

  • Liana Apostolova, MD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13)Month 0, Month 12, Month 24, Month 36 (EOAD/EOnonAD only) and Month 48 (EOAD/EOnonAD only)

    The ADAS-Cog is an in-person examiner-administered, structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained.