The effect of cognitive function as measured by repeated cognitive measures after 12 weeks treatment with donepezil

Study identifier:D2285M00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomised, Double-blind, Placebo-controlled, Parallel design, Multicentre Study in Patients with Mild to Moderate Alzheimer’s Disease to Investigate the Effect on Cognitive Function as Measured by Repeated CogState Testing in Relation to Effects on Traditional Cognitive Measures After 12 weeks

Medical condition

Alzheimer's disease

Phase

N/A

Healthy volunteers

Study drug

Donepezil, Placebo to match Aricept

Sex

All

Actual Enrollment

155

Study type

Interventional

Age

55 Years - 85 Years

Date

Study Start Date: 01 Dec 2009

Primary Completion Date: 01 Jan 2011

Study Completion Date: 01 Jan 2011

Study design

Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Reearch Site

QUEBEC, Canada

Location

Research Site

Ottawa, Ontario, Canada

Location

Research Site

Gatineau, Quebec, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Quebec, Quebec, Canada

Location

Research Site

CALLAO, Peru

Location

Research Site

Lima, Peru

Location

Research Site

Callao, Lima, Peru

Arms	Assigned Interventions
Active Comparator: 1 5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)	Drug: Donepezil 5 mg capsule, orally, once daily, first 14 days of treatment Other Name: Aricept Drug: Donepezil 10 mg, orally, once daily, for remaining 70 days of treatment Other Name: Aricept
Placebo Comparator: 2	Drug: Placebo to match Aricept Placebo capsule, orally, 84 days of treatment

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1246&filename=CSR-D2285M00010.pdf
Download
CSR-D2285M00010.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Malene Jensen

Study Delievery Director, AstraZeneca

The effect of cognitive function as measured by repeated cognitive measures after 12 weeks treatment with donepezil

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Reearch Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1246&filename=CSR-D2285M00010.pdf

CSR-D2285M00010.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator