dementia mild cognitive impairment
Conditions
Interventions
Not applicable, CSF samples will be obtained from patients under the pharma
protocol.
Sponsors
Roche Diagnostics International Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In the present study, CSF samples collected for screening for the associated pharma trial will be measured. No further patient inclusion criteria apply. Specifically, the CSF samples will be collected from subjects with either MCI due to AD or mild AD dementia who meet the screening criteria as described in the pharma phase 2 clinical trial protocol and are able to undergo CSF sampling at screening. Please see the pharma clinical trial protocol for patient inclusion and exclusion criteria for the clinical trial. Approximately 600 subjects will be screened via CSF in order to test for eligibility and randomize the planned quantity of subjects in the pharma trial. CSF specimen eligibility criteria for the performance study: - frozen at sample receipt - not visibly hemolyzed - approx. 500µl sample volume
Exclusion criteria
Exclusion criteria: In the present study, CSF samples collected for screening for the associated pharma trial will be measured. No further patient exclusion criteria apply. CSF specimen eligibility criteria for the performance study: - frozen at sample receipt - not visibly hemolyzed - approx. 500µl sample volume
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of β-Amyloid (1-42) (Aβ 42) and Phospho-Tau (181P) (pTau) in the screening samples of the phase 2 clinical trial of 247AD201 (BIIB080) | — |
Countries
Netherlands
Outcome results
None listed