Longitudinal Early-onset Alzheimer's Disease Study Protocol
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 (EOnonAD) participants, and (3) cognitively normal (CN) control participants.
• 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
• 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 at least 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 or Spanish if enrolled in the U.S.
• Fluent in English, Spanish, Dutch or Swedish for sites outside the U.S., according to site's spoken language(s).
• 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 or Spanish if enrolled in the U.S.
⁃ Fluent in English, Spanish, Dutch or Swedish for sites outside the U.S., according to site's spoken language(s).