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Study Details

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

The Longitudinal Early-onsetAlzheimer's Disease Study (LEADS) is a non-randomized, natural history,non-treatment study designed to look at disease progression in individuals withearly onset Alzheimer's disease (EOAD). Clinical/cognitive, imaging, biomarker,and genetic characteristics will be assessed across two cohorts: (1)individuals with cognitive impairment and (2) cognitively normal controlparticipants. The primary objectives of the LEADS study are to: collectlongitudinal assessments and biomarker data; to compare baseline andlongitudinal cognitive and functional characteristics between cognitivelyimpaired and cognitively normal individuals, and EOAD and Late OnsetAlzheimer's Disease (LOAD) individuals from the Alzheimer's DiseaseNeuroimaging Initiative (ADNI); and to study the associations of longitudinalclinical and cognitive assessments with multimodal imaging and biofluid markersthat capture different elements of the AD pathophysiological cascade.

Inclusion Criteria (Cognitively Impaired Cohort Only):

  • Meets NIA-AA criteria for MCI due to AD or probable AD dementia
  • Have capacity to provide informed consent (IC) or has a legally authorized representative or guardian who provides IC
  • Age between 40-64 years (inclusive) at the time of consent
  • 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 participant's cognitive and functional performance
  • 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

Inclusion Criteria (Cognitively Normal Cohort Only):

  • Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
  • Have capacity to provide informed consent
  • Age between 40-64 years (inclusive) at the time of consent
  • 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 participant's cognitive and functional performance
  • 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
Rogalski, EmilyRogalski, Emily
NCT03507257 STU00207242
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