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

Recruiting

The Longitudinal Early-Onset Alzheimer's Disease Study (LEADS) is a 2-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 1-year comparison.

Minimum Age Maximum Age Gender Healthy Volunteers
40 Years 64 Years All Yes
April 30, 2018
August 31, 2023
500

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
  • Amyloid-positive status, as determined by positron emission tomography (PET) scan

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

  • 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 less than 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

Participants will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, brain imaging scans (including PET and MRI), and cerebral spinal fluid collection. 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.

Name City State Zip Status Primary Contact
University of California, San Francisco
San Francisco California 94121 Recruiting Julie Pham

Julie.pham@ucsf.edu
Mayo Clinic, Jacksonville
Jacksonville Florida 32224 Recruiting Sabrina Bunn
904-953-3930
bunn.sabrina@mayo.edu
Northwestern University
Chicago Illinois 60611 Recruiting Kristine Lipowski
312-503-2486
k-lipowski@northwestern.edu
Indiana University
Indianapolis Indiana 47405 Recruiting IU LEADS Team
317-963-7436
iuLEADS@iupui.edu
Massachusetts General Hospital
Boston Massachusetts 02114 Recruiting Ryn Flaherty
617-726-1455
rflaherty3@mgh.harvard.edu
Mayo Clinic, Rochester
Rochester Minnesota 55905 Suspended

Washington University, St. Louis
Saint Louis Missouri 63130 Recruiting Lisa Cash
314-362-7093
cashl@mir.wustl.edu
University of Pennsylvania
Philadelphia Pennsylvania 19104 Recruiting Grace Stockbower
215-746-3949
grace.stockbower@uphs.upenn.edu
Butler Hospital
Providence Rhode Island 02906 Recruiting Sara Hooley
401-455-6403
shooley@butler.org
Houston Methodist Hospital
Houston Texas 77030 Recruiting Tierra Ledet

tledet@houstonmethodist.org

Liana Apostolova

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

Name Role Affiliation
Liana Apostolova, MD Principal Investigator Indiana University

Name Phone Email
Nikki Mehdiyoun 317-963-4593 nmehdiyo@iupui.edu

NCT03507257

Longitudinal Early-onset Alzheimer's Disease Study Protocol