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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00348192
Date of registration: 30/06/2006
Primary sponsor: GlaxoSmithKline
Public title: SB-742457 And Donepezil In Alzheimer's Disease
Scientific title: A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects With Mild to Moderate Alzheimer's Disease
Date of first enrolment: May 2006
Target sample size: 200
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Countries of recruitment
Argentina Austria Bulgaria Chile Estonia Germany Hungary Russian Federation
Slovakia United Kingdom
Name:   GSK Clinical Trials, MD
Affiliation:  GlaxoSmithKline
Key inclusion & exclusion criteria

Inclusion criteria:

- Clinical diagnosis of probable mild-to-moderate Alzheimer's Disease as determined by
the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24.

- Subjects and their caregivers must provide informed consent prior to study entry.

- Adequate blood pressure and laboratory values.

Exclusion criteria:

- Females of child-bearing potential.

- Have other causes of dementia such as vascular damage, depression, bipolar affective
disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.

- Subjects taking medication for Alzheimers disease or centrally acting agents which
might impact study outcomes.

- Subjects taking agents for which there is a theoretical risk of interaction with
SB-742457 or donepezil.

- Subjects with conditions which might be exacerbated by exposure to donepezil.

- Subjects with known hypersensitivity to sunlight or seizures.

Age minimum: 50 Years
Age maximum: 85 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Alzheimer's Disease
Drug: donepezil
Drug: SB-742457
Primary Outcome(s)
Change in cognition and function after 24 weeks.
Secondary Outcome(s)
Change in behavioral symptoms, activities of daily living and caregiver burden after 24 weeks Changes in all symptoms at 8 and 12 weeks Safety and tolerability PK (pharmacokinetic) profiling. Efficacy related to ApoE and HTR6 status
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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