Effect of Aricept on Biomarkers (Acetylcholine, sAPP Alpha) In Cerebrospinal Fluid
It is hypothesized that the acetylcholinesterase inhibitor, donepezil, will increase acute cerebrospinal fluid (CSF) actylcholine levels in healthy volunteers following a 5mg single dose oral administration.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||A Methodology Study To Evaluate Cerebrospinal Fluid Acetylcholine Following A Single Dose Administration Of Donepezil In Healthy Subjects|
- Mean post-dose vs predose change in CSF acetycholine levels in donepezil compared to placebo control group. [ Time Frame: 6 hrs ] [ Designated as safety issue: Yes ]
- Mean post-dose vs predose change in CSF histamine metabolites, sAPPalpha and inflammatory endpoints [ Time Frame: 6hrs ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
DNA, plasma, CSF
|Study Start Date:||October 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Drug: donepezil (Aricept)
Other Name: Aricept
Sampling method based upon estimates of intra-subject biomarker variability.