The effects of two marketed drugs on cognitive function
Research type
Research Study
Full title
An Exploratory Double-blind, Placebo-controlled, Cross-over Method Validation Study to Evaluate the Effects of Scopolamine 0.5 mg and Donepezil 10 mg on Cognitive Function in Healthy Male Subjects
IRAS ID
139221
Contact name
Tania Hugo
Contact email
Sponsor organisation
PAREXEL International
Research summary
This study is a method study. Only two marketed products will be administered, scopolamine and donepezil. In this method study, scopolamine is used to induce a cognitive deficit and donepezil is used to reverse the effects of scopolamine.
This study will aim to prove that a set of tests which evaluates cognitive and psychomotor functions (like problem solving and reasoning, attention, learning and memory) is valid to use in the early studies when new drugs are tested; specifically new drugs which are supposed to improve cognitive functions.
This study will take place at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ. This study will recruit healthy males between the ages of 18 and 55 years.
REC name
London - City & East Research Ethics Committee
REC reference
13/LO/1636
Date of REC Opinion
24 Dec 2013
REC opinion
Further Information Favourable Opinion