Dominantly Inherited Alzheimer Disease (DIAD)
Conditions
Brief summary
The primary and secondary endpoints measures will be collected through the DIAN Obs protocol. The primary endpoint for the interim analysis is the change from ART baseline to year 1 or year 2 in amyloid Pittsburgh compound B (PiB) PET standardized uptake value ratio (SUVR). The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating – Sum of Boxes (CDR-SB).
Detailed description
The secondary endpoint analysis will be the change from ART baseline to year 5 in the following assessments: imaging (amyloid PET, tau PET), clinical (Functional Assessment Scale), plasma and CSF biomarkers of disease progression including Aβ42/40, tau species (%phosphorylated tau217, 205, 231), total tau, and microtubule-binding region (MTBR) species, e.g. MTBR-243. These assessments are collected at the initial DIAN Obs Visit (which coincides with DIAN‐TU‐003 V2) and...Truncated due to limit
Interventions
DRUGLecanemab
Sponsors
Washington University School Of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary and secondary endpoints measures will be collected through the DIAN Obs protocol. The primary endpoint for the interim analysis is the change from ART baseline to year 1 or year 2 in amyloid Pittsburgh compound B (PiB) PET standardized uptake value ratio (SUVR). The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating – Sum of Boxes (CDR-SB). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint analysis will be the change from ART baseline to year 5 in the following assessments: imaging (amyloid PET, tau PET), clinical (Functional Assessment Scale), plasma and CSF biomarkers of disease progression including Aβ42/40, tau species (%phosphorylated tau217, 205, 231), total tau, and microtubule-binding region (MTBR) species, e.g. MTBR-243. These assessments are collected at the initial DIAN Obs Visit (which coincides with DIAN‐TU‐003 V2) and...Truncated due to limit | — |
Countries
France
Outcome results
None listed