Northwestern University Feinberg School of Medicine
Mesulam Center for Cognitive Neurology and Alzheimer’s Disease
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Study Details

Longitudinal Early-onset Alzheimer’s Disease Study (LEADS)
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 Alzheimer's disease (EOAD). Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across two cohorts: (1) individuals with EOAD and (2) 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 Alzheimer's disease (EOAD) 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
Inclusion Criteria (EOAD Cohort Only):

-Meets NIA-AA criteria for MCI due to AD or probable AD dementia
-Have a global CDR score ≤ 1.0
-Have capacity to provide informed consent (IC) or has a legal authorized representative or guardian who provides IC
-Amyloid positive status (PET scan with evidence of elevated amyloid)
-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 participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI
-Willing and able to complete longitudinal study procedures aside from LP which is an optional procedure
-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 (CN) Cohort Only):

-Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
-Have a global CDR score = 0
-Have capacity to provide informed consent
-Have a Mini-Mental State Exam score between 26-30 (inclusive). Exceptions may be made for participant with less than 8 years of education at the discretion of the Site PI
-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 participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI
-Willing and able to complete longitudinal study procedures aside from LP which is an optional procedure
-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, Emily JoyRogalski, Emily Joy
NCT03507257 STU00207242
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For more information on this study please contact us:

Muse, Brittanie
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