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

  • Study Director at UCSF: Gil Rabinovici, MD
  • Study Director (overall): Liana Apostolova, Indiana University School of Medicine 
  • Sponsor: Alzheimer’s Therapeutic Research Institute, National Institute on Aging (NIA), Alzheimer’s Association
  • Recruiting? Yes
  • Official study title: Longitudinal Early-Onset Alzheimer’s Disease Study Protocol (LEADS)
  • Conditions studied: Cognitively impaired participants (i.e., early-onset Alzheimer’s disease (EOAD) and early-onset non-Alzheimer’s disease (EO-nonAD)) and cognitively normal (CN) control participants
  • ClinicalTrials.gov Identifier: NCT03507257

Purpose of the Study

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 (EO-nonAD) participants, and (3) cognitively normal (CN) control participants.

The primary objectives of the LEADS study are to:

  • collect longitudinal assessments and biomarker data in individuals with early-onset cognitive impairment (EOAD/EO-nonAD) 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.

Study Details

Enrolled participants must be 40–64 (inclusive) years of age, with MCI due to AD or probable AD dementia (EOAD/EO-nonAD), or have no significant memory impairment (CN). Approximately 500 participants with cognitive impairment (EOAD/EO-nonAD) and 100 CN participants will be enrolled at approximately 20 sites in the United States.

    What to Expect

    Cognitively impaired participants will take part in the study for 24 months; CN participants will take part in the study for 12 months. Participants will undergo annual longitudinal clinical and cognitive assessments, a blood draw and genetic tests, two PET scans (amyloid and tau), an MRI brain scan, and an optional cerebrospinal fluid (CSF) collection.

    Contact Information

    If you are interested in participating in this study or have any questions, please contact the study coordinator, Julie Pham at [email protected] or 415.502.7133.