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 cohort
| Condition(s) | Early Onset Alzheimer Disease, Alzheimer Disease, Mild Cognitive Impairment |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 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 |
| Ages | 40 Years to 64 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Indiana University |
| Locations | Sun City, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States (+17 more sites) |
| Start date | 2018-04-30 |
| NCT ID | NCT03507257 |
| Official listing | https://clinicaltrials.gov/study/NCT03507257 |