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Longitudinal Early-Onset Alzheimer's Disease Study (LEADS)

Start: April 30, 2018
End: August 31, 2023
Enrollment: 600

What Is This Study About?

The Longitudinal Early-Onset Alzheimer's Disease Study (LEADS) is a two-year observational study designed to look at disease progression in adults with early-onset Alzheimer's disease. Researchers are also recruiting cognitively normal volunteers for a one-year comparison. Participants will have clinical and cognitive assessments, computerized cognitive tests, biomarker and genetic tests, brain imaging scans (including positron emission tomography (PET) and MRI), and cerebral spinal fluid collection (optional). Researchers will compare data among participants and also to data from people with late-onset Alzheimer's disease to study different elements of disease progression.

Do I Qualify To Participate in This Study?

Minimum Age: 40 Years

Maximum Age: 64 Years

Must have:

Early-Onset Alzheimer's Participants

  • Meet criteria for mild cognitive impairment due to Alzheimer's disease or probable Alzheimer's disease dementia
  • Global Clinical Dementia Rating score of 1 or less
  • Capacity to provide informed consent or legally authorized representative or guardian who can provide consent

Cognitively Normal Participants

  • Meet criteria for cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
  • Have a global Clinical Dementia Rating score of 0
  • Mini-Mental State Examination score of 26 to 30 (exceptions may be made for less than 8 years of education)

All Participants

  • Study partner who spends at least 10 hours per week with the participant, is generally aware of the person's daily activities, and can provide information about cognitive and functional performance; if the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements may be considered
  • 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
  • Fluent in English

Must NOT have:

  • Non-Alzheimer's disease dementia
  • Two or more first-degree relatives with a history of early-onset dementia (unless known mutations in APP, PSEN1, PSEN2 have been excluded)
  • Known mutation in APP, PSEN1, PSEN2, or other autosomal dominant genes associated with neurodegenerative disorders
  • Inability to undergo MRI, including claustrophobia, pacemaker, select implants, and fragments or foreign objects in the eyes, skin or body
  • Lifetime history of a brain disorder (except for headache)
  • Evidence of infection or focal lesions, cortical strokes, or multiple lacunes on MRI
  • Significant systemic illness or unstable medical condition that could interfere with study participation
  • Medical radiation exposure higher than is safe, as deemed by investigators
  • Investigational agents in past 30 days
  • Previous enrollment in a therapeutic trial targeting amyloid or tau
  • Participation in other clinical studies with neuropsychological measures, except the National Alzheimer's Coordinating Center Uniformed Data Set
  • Lifetime history of schizophrenia spectrum disorders
  • Diagnosis of mania or bipolar disorder in past year
  • Moderate or severe substance abuse in past 6 months (nicotine or caffeine allowed)
  • Suicidal behaviors in the past year or active suicidal ideations
  • Reside in a 24-hour care skilled nursing facility
  • History of torsades de pointes or taking medications known to prolong the QT interval
  • Corrected QT interval greater than or equal to 458 milliseconds in males or 474 milliseconds in females
  • For optional lumbar puncture procedure, exclusions include inability to undergo procedure; abnormal clinical laboratory values; suspected elevated intracranial pressure, malformation, or mass lesion; and anticoagulant medication use

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Study Contact
Beenish Qureshi

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Banner Sun Health Research Institute
Sun City, AZ 85351
Kelly Clark
University of California, Los Angeles
Los Angeles, CA 90095
Diana Chavez
Stanford University
Palo Alto, CA 94304
Tricia Cunningham
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University of California, San Francisco
San Francisco, CA 94121
Karen Smith
District of Columbia
Georgetown University
Washington, DC 20057
Kelly McCann
Mayo Clinic, Jacksonville
Jacksonville, FL 32224
Anton Thomas
Wien Center
Miami Beach, FL 33140
Rosemarie Rodriguez
Emory University
Atlanta, GA 30322
Jennifer Chung
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Northwestern University
Chicago, IL 60611
Brittanie Muse
Indiana University
Indianapolis, IN 47405
Johns Hopkins University
Baltimore, MD 21218
Toni White
Massachusetts General Hospital
Boston, MA 02114
Ana Eustace
Mayo Clinic, Rochester
Rochester, MN 55905
Emily Berg
Washington University, St. Louis
Saint Louis, MO 63130
Mary Banach
New York
Columbia University
New York, NY 10032
Betina Idnay
University of Pennsylvania
Philadelphia, PA 19104
Laura Schankel
Rhode Island
Butler Hospital
Providence, RI 02906
Outreach Team
Houston Methodist Hospital
Houston, TX 77030
Stephanie Wenzlawsh

Who Sponsors This Study?

Lead: Indiana University

Collaborator Sponsor

  • Alzheimer's Therapeutic Research Institute
  • National Institute on Aging (NIA)
  • Alzheimer's Association
  • National Alzheimer's Coordinating Center (NACC)

Source: ID: NCT03507257