Disease progression in early onset cognitive impairment

Longitudinal Early-onset Alzheimer's Disease Study Protocol (LEADS)



Brief 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 (EO-nonAD) participants,and
(3) cognitively normal (CN) control participants.

Detailed 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
1.      AD or
2.      probable AD dementia (EOAD / EO-nonAD), or
3.      have no significant memory impairment (CN).

Approximately 500 participants with cognitive impairment (EOAD / EO-nonAD) and 100 CN participants will be enrolled at approximately 20 sites in the United States. 
Cognitively impaired participants will take part in the study for 24 months; CN participants will take part in the study for 12 months.

Participants will undergo 
  1. - Longitudinal clinical and cognitive assessments, 
  2. - Computerized cognitive batteries, 
  3. - Biomarker and genetic tests, 
  4. - PET (amyloid and tau) and 
  5. - MRI brain scans, and 
  6. - Optional cerebrospinal fluid (CSF) collection.

Primary objectives of the LEADS study are to:

  • Collect longitudinal assessments and biomarker data in individuals with early onset cognitive impairment (EOAD / EO-nonAD) and cognitively normal (CN) controls;
  • To compare baseline and longitudinal cognitive and functional characteristics, between EOAD and CN, and EOAD and Late Onset Alzheimer's Disease (LOAD) from the Alzheimer's Disease Neuroimaging Initiative (ADNI); and
  • To study the associations of longitudinal clinical and cognitive assessments with multimodal imaging and biofluid markers that capture different elements of the AD patho-physiological cascade









Source:  https://clinicaltrials.gov/ct2/show/record/NCT03507257?recrs=ab&cond=Alzheimer+Disease%2C+Early+Onset&draw=2&rank=7

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