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NCT03507257 · ClinicalTrials.gov registry record
Longitudinal Early-onset Alzheimer's Disease Study Protocol
A clinical trial of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Indiana University.
- Recruiting
- Registry status
- 850
- Enrollment target
- 20
- Study locations
NCT03507257: Recruiting study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Indiana University.
NCT03507257 is a study of Alzheimer Disease and Mild Cognitive Impairment that is actively recruiting participants, run by Indiana University. The registered enrollment target is 850 participants, below the 2,748-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03507257, a study of Alzheimer Disease and Mild Cognitive Impairment, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- 850 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Flortaucipir
- DRUG Florbetaben
- DRUG Fluorodeoxyglucose
Study Locations (20)
California
- University of California, Los Angeles - Los Angeles
- Stanford University - Palo Alto
- University of California, San Francisco - San Francisco
Florida
- Mayo Clinic, Jacksonville - Jacksonville
- Wien Center - Miami Beach
Other
- Fleni - Buenos Aires
- Amsterdam UMC - Amsterdam
Arizona
- Banner Sun Health Research Institute - Sun City
District of Columbia
- Georgetown University - Washington D.C.
Georgia
- Emory University - Atlanta
Illinois
- Northwestern University - Chicago
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2026-05-31 |
What NCT03507257 shows while recruiting
NCT03507257 is an observational study that tracks outcomes without assigning an intervention. The registered 850 participants enrollment target is mid-sized for trials with a published cap, below the 2,748-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (69% lower).
The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 3 interventions - of which Flortaucipir is the first listed.
NCT03507257 names 20 study sites across 16 states, led by California, Florida, Other.
Frequently Asked Questions
What is clinical trial NCT03507257 about?
NCT03507257 is a clinical study titled "Longitudinal Early-onset Alzheimer's Disease Study Protocol". 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...
What is the current status of trial NCT03507257?
This trial is currently recruiting. The enrollment target is 850 participants. The study started on 2018-04-30. Estimated completion is 2026-05-31.
What conditions does trial NCT03507257 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Early Onset Alzheimer Disease.
What interventions are being tested in trial NCT03507257?
The interventions under investigation include: Flortaucipir (DRUG), Florbetaben (DRUG), Fluorodeoxyglucose (DRUG).
Who is sponsoring clinical trial NCT03507257?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03507257 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03507257's enrollment target sits among peer trials
850 36th of 306 higher than 271 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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