MedTrace Logo

Longitudinal Early-onset Alzheimer's Disease Study Protocol

NCT03507257 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 850

Last updated 2026-02-18

No results posted yet for this 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.

Conditions

Interventions

DRUG

Flortaucipir

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.

DRUG

Florbetaben

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.

DRUG

Fluorodeoxyglucose

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.

Sponsors & Collaborators

  • Alzheimer's Therapeutic Research Institute

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Alzheimer's Association

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Liana Apostolova, MD · Indiana University

Eligibility

Min Age
40 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507257 on ClinicalTrials.gov