Longitudinal Early-onset Alzheimer's Disease Study Protocol
Indiana University
Summary
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.
Description
The LEADS study is a non-randomized, natural history, non-treatment study. Enrolled participants must be 40 - 64 (inclusive) years of age, with MCI due to AD or probable AD dementia (cognitively impaired participants) or have no significant memory impairment (cognitively normal \[CN\] participants). Approximately 850 participants with cognitive impairment (650 with early onset Alzheimer's Disease \[EOAD\] and 200 with early onset non-Alzheimer's Disease \[EOnonAD\]) and 100 CN participants will be enrolled at approximately 20 sites in the United States. At approximately 5 sites outside of the…
Eligibility
- Age range
- 40–64 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria for Cognitively Impaired (EOAD and EOnonAD) Cohorts Only: 1. Meets NIA-AA criteria for MCI due to AD or probable AD dementia 2. Have a global CDR score ≤ 1.0 3. Have capacity to provide informed consent (IC) or has a legal authorized representative or guardian who provides IC 4. Age between 40-64 years (inclusive) at the time of consent 5. 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…
Interventions
- DrugFlortaucipir
All participants will receive a single bolus intravenous injection of approximately 10 mCi (+/- 10%, 20μg mass dose) of flortaucipir (18F-AV-1451). At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
- DrugFlorbetaben
All participants will receive a single bolus intravenous injection of approximately 8 mCi +/- .8mCi of florbetaben (AV-45). At approximately 90-minutes (+/- 10 minutes) post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
- DrugFluorodeoxyglucose
All participants will receive a single bolus intravenous injection of approximately 5 mCi (+/- 10%, 0.5 mCi) of fluorodeoxyglucose. At approximately 30 minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
Locations (23)
- Banner Sun Health Research InstituteSun City, Arizona
- University of California, Los AngelesLos Angeles, California
- Stanford UniversityPalo Alto, California
- University of California, San FranciscoSan Francisco, California
- Georgetown UniversityWashington D.C., District of Columbia
- Mayo Clinic, JacksonvilleJacksonville, Florida