Actively Recruiting
Longitudinal Early-onset Alzheimer's Disease Study Protocol
Led by Indiana University · Updated on 2026-02-18
850
Participants Needed
23
Research Sites
421 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
A
Alzheimer's Therapeutic Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Longitudinal Early-onset Alzheimer's Disease Study Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets NIA-AA criteria for mild cognitive impairment due to Alzheimer's Disease or probable Alzheimer's dementia (for cognitively impaired cohorts)
- Global Clinical Dementia Rating (CDR) score of 1.0 or less for cognitively impaired participants
- Capacity to provide informed consent or a legal representative able to provide consent
- Age between 40 and 64 years inclusive at consent
- Has a study partner who spends at least 10 hours per week with the participant and is aware of their daily activities
- Willing and able to complete longitudinal study procedures except optional lumbar puncture
- Not pregnant or lactating; women must be two years post-menopausal, surgically sterile, or have a negative pregnancy test before each PET scan
- Fluent in English or Spanish for U.S. sites; fluent in English, Spanish, Dutch, or Swedish for non-U.S. sites
- Cognitively normal participants must have a global CDR score of 0 and a Mini-Mental State Exam score between 26 and 30 (exceptions possible for less education)
You will not qualify if you...
- Meets core clinical criteria for non-Alzheimer's dementia
- Two or more first-degree relatives with early-onset dementia suggestive of autosomal dominant inheritance unless known mutations have been excluded
- Known CLIA certified mutation in autosomal dominant Alzheimer's genes or other related genes
- Contraindications to 3T MRI such as claustrophobia or incompatible implants
- History of brain disorders other than dementia-causing disorder except headache (exceptions possible)
- MRI evidence of infection, focal lesions, cortical strokes, or multiple lacunes affecting cognition
- Significant systemic illness or unstable medical condition affecting protocol compliance
- More than one nuclear medicine study for research in prior 12 months without PET Core approval
- Use of investigational agents within 30 days before entry
- Prior participation in therapeutic trials targeting amyloid or tau
- Current or past 12 months diagnosis of schizophrenia spectrum disorders or recent severe psychiatric conditions
- Current moderate or severe substance abuse within past 6 months
- Suicidal behaviors or active ideations within past 12 months
- Residency in 24-hour skilled nursing facility at screening
- Contraindications or abnormal labs preventing lumbar puncture if opting for procedure
- Other reasons deemed ineligible by the Site Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
Completed
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
4
University of California, San Francisco
San Francisco, California, United States, 94121
Actively Recruiting
5
Georgetown University
Washington D.C., District of Columbia, United States, 20057
Completed
6
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
7
Wien Center
Miami Beach, Florida, United States, 33140
Completed
8
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Northwestern University
Chicago, Illinois, United States, 60611
Completed
10
Indiana University
Indianapolis, Indiana, United States, 47405
Actively Recruiting
11
Johns Hopkins University
Baltimore, Maryland, United States, 21218
Actively Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
13
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
14
Washington University, St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
15
Columbia University
New York, New York, United States, 10032
Actively Recruiting
16
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
17
Butler Hospital
Providence, Rhode Island, United States, 02906
Actively Recruiting
18
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
19
Fleni
Buenos Aires, Argentina, C1428 CABA
Actively Recruiting
20
Amsterdam UMC
Amsterdam, Netherlands, 1081 HZ
Not Yet Recruiting
21
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 8041
Actively Recruiting
22
Lund University
Malmö, Sweden, 214 28
Not Yet Recruiting
23
University College London
London, United Kingdom, WC1N 3BG
Not Yet Recruiting
Research Team
I
IU LEADS Team
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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