The study, called the Longitudinal Early-onset Alzheimer’s Disease Study, or LEADS for short, will enroll approximately 500 participants with early onset cognitive impairment aged 40-64 over the course of two years. A cognitively normal cohort of approximately 100 participants will also be followed for a one year comparison.
Eligible participants will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, brain imaging scans (including PET and MRI), and optional cerebral spinal fluid collection. Researchers will compare participants with early onset cognitive impairment to those with normal memory, as well as to people with more common late-onset AD to study different elements of disease progression. This work will bridge the gap toward future clinical trials and establish an early-onset AD clinical trial network in the U.S.
1. Screening & Baseline: All procedures, testing, scans and baseline visits occur over the
course of 45 days.
2. Active Study Phase: Participants who are cognitively normal will have one follow up visit a year
after the baseline assessments. Participants with early onset cognitive impairment will have
two follow up visits at year one and year two after their baseline visits.
While the risk of Alzheimer’s disease increases with advancing age, approximately 5 percent of Alzheimer’s patients develop symptoms before age 65 (early onset), with less than 10 percent of these patients carrying known genetic mutations for the disease. Patients with early-onset AD are understudied and are commonly excluded from clinical research and therapeutic trials because of their young age or milder memory loss. This multi-site longitudinal observational study will help researchers better understand how people develop this rare variant of Alzheimer’s disease.
To learn more visit butler.org/memory or call the Memory and Aging Program Outreach Team at (401) 455-6402.