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Longitudinal Early-onset Alzheimer's Disease Study Protocol | Clinical Trials | Clareo Health

RECRUITING

Longitudinal Early-onset Alzheimer's Disease Study Protocol

NCT03507257•Indiana University

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.

Detailed Description

The LEADS study is a non-randomized, natural history, non-treatment study. Enrolled participants must be 40 - 64 (inclusive) years of age, with MCI due to AD or probable AD dementia (cognitively impaired participants) or have no significant memory impairment (cognitively normal \[CN\] participants). Approximately 850 participants with cognitive impairment (650 with early onset Alzheimer's Disease \[EOAD\] and 200 with early onset non-Alzheimer's Disease \[EOnonAD\]) and 100 CN participants will be enrolled at approximately 20 sites in the United States. At approximately 5 sites outside of the United States, approximately 400 cognitively impaired participants and 10 CN participants will be enrolled. Cognitively impaired participants will take part in the study for 48+ months; CN participants will take part in the study for 24+ months. Participants will undergo longitudinal clinical and cognitive assessments, computerized cognitive tests, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI brain scans, and optional cerebrospinal fluid (CSF) collection. Participants will be invited to consider autopsy brain donation The primary objectives of the LEADS study are to: * collect longitudinal assessments and biomarker data in individuals with early onset cognitive impairment (EOAD / EOnonAD) and cognitively normal (CN) controls; * to compare baseline and longitudinal cognitive and functional characteristics, between EOAD and CN, and EOAD and Late Onset Alzheimer's Disease (LOAD) from the Alzheimer's Disease Neuroimaging Initiative (ADNI); and * to study the associations of longitudinal clinical and cognitive assessments with multimodal imaging and biofluid markers that capture different elements of the AD pathophysiological cascade

Eligibility

Age

40 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Meets NIA-AA criteria for MCI due to AD or probable AD dementia
•2. Have a global CDR score ≤ 1.0
•3. Have capacity to provide informed consent (IC) or has a legal authorized representative or guardian who provides IC
•4. Age between 40-64 years (inclusive) at the time of consent
•5. Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends at least 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI
•6. Willing and able to complete longitudinal study procedures aside from LP which is an optional procedure
•7. Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
•8. Fluent in English or Spanish if enrolled in the U.S.
•9. Fluent in English, Spanish, Dutch or Swedish for sites outside the U.S., according to site's spoken language(s).
•1. Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
+9 more criteria

Exclusion Criteria

•1. Meets core clinical criteria for non-AD dementia
•2. Two or more first degree relatives with a history of early-onset dementia suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2, MAPT, GRN and C9ORF72 have been excluded
•3. Known CLIA certified mutation in an ADAD gene (APP, PSEN1, PSEN2), or other autosomal dominant genes associated with other neurodegenerative disorders (MAPT, GRN, C9ORF72)
•4. Contraindications to 3T MRI (e.g., claustrophobia, pacemaker, select aneurismal clip, artificial heart valve, select ear implants, select stents incompatible with 3T MRI, metal fragments or foreign objects in the eyes, skin or body, etc.)
•5. Lifetime medical history of a brain disorder other than the disorder causing dementia except for headache (exceptions are allowed at the discretion of the Site PI - e.g., seizure disorder thought to be due to EOAD).
•6. MRI scan with evidence of infection or focal lesions, cortical strokes, multiple lacunes (single lacune is allowable unless it meets criteria for strategic lacune affecting cognition)
•7. Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the Site PI)
•8. Research radiation exposure will be assessed by the study physician. If the candidate participant has had more than one nuclear medicine study in the prior 12 months for research-related purposes, study inclusion will require approval from the PET Core
•9. Investigational agents are prohibited 30 days prior to entry
•10. Previous enrollment in a therapeutic trial targeting amyloid or tau.
+9 more criteria

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

Key Dates

Start Date

April 30, 2018

Primary Completion Date

May 31, 2026

Completion Date

May 31, 2026

Last Updated

February 18, 2026

Enrollment

850

ESTIMATED participants

Conditions

Early Onset Alzheimer DiseaseAlzheimer DiseaseMild Cognitive Impairment

Interventions

Flortaucipir

DRUG

Florbetaben

DRUG

Fluorodeoxyglucose

DRUG

Contacts

IU LEADS Team

CONTACT

317-963-7436 iuLEADS@iupui.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Longitudinal Early-onset Alzheimer's Disease Study Protocol

Inclusion Criteria

Exclusion Criteria

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