The Longitudinal Early-onset Alzheimer's Disease Study (LEADS): Framework and methodology.

Area of Science:

• Neurology
• Neuroscience
• Biomarkers

Background:

• Early-onset Alzheimer's disease (EOAD) is often excluded from research due to unique patient characteristics.
• Understanding EOAD is crucial for developing effective Alzheimer's disease (AD) treatments.

Purpose of the Study:

• Define clinical, imaging, and fluid biomarker profiles of EOAD.
• Develop sensitive measures for cognitive and biomarker assessment in EOAD.
• Establish a network to facilitate future EOAD clinical trials.

Main Methods:

• Longitudinal study of 700 participants (EOAD, non-AD dementia, controls) and 100 age-matched controls.
• Comprehensive assessments including cognitive tests, MRI, PET scans (Florbetaben, Flortaucipir), and fluid biomarker collection (CSF, blood).
• Collection of DNA, RNA, plasma, serum, PBMCs, and post-mortem data for detailed analysis.

Main Results:

• The study is designed to characterize EOAD patients, including those with and without amyloid pathology.
• It will identify sensitive cognitive and biomarker measures relevant to EOAD.
• A trial-ready network will be established to support future therapeutic interventions.

Conclusions:

• The Longitudinal EOAD Study (LEADS) will provide a comprehensive dataset and network for EOAD research.
• This resource is expected to accelerate the development and implementation of clinical trials for EOAD.
• Understanding the specific genetic, biological, and clinical aspects of EOAD is essential for advancing treatment strategies.