The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024660
• Other study ID #: D2285M00010
• Status: Completed
• Phase: Phase 0
• First received: December 2, 2009
• Last updated: February 6, 2011
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health CanadaPeru: Ethics CommitteePeru: General Directorate of Pharmaceuticals, Devices, and DrugsPeru: Instituto Nacional de SaludPoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: The Central Register of Clinical TrialsSouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery. The results at one month will be compared with the results at 3 months to evaluate this.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of probable AD according to NINCDS-ADRDA criteria.

• The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patient's home.

• Patient and caregiver should understand, speak, and read local language.

Exclusion Criteria:

• Significant neurological disease or dementia other than AD, e.g., mixed dementia, frontotemporal dementia, and Parkinson's Disease.

• Females of child bearing potential

• Impaired vision or hearing

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Donepezil
5 mg capsule, orally, once daily, first 14 days of treatment
• Donepezil
10 mg, orally, once daily, for remaining 70 days of treatment
• Placebo to match Aricept
Placebo capsule, orally, 84 days of treatment

Locations

Country	Name	City	State
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Reearch Site	Quebec
Canada	Research Site	Quebec
Peru	Research Site	Callao	Lima
Peru	Research Site	Callao
Peru	Research Site	Lima
Poland	Research Site	Chojnice
Poland	Research Site	Gdansk
Poland	Research Site	Kalisz
Poland	Research Site	Pila
Poland	Research Site	Poznan
Poland	Research Site	Scinawa
Poland	Research Site	Sopot
Poland	Research Site	Warszawa
South Africa	Research Site	Cape Town	Western Cape
South Africa	Research Site	Roodepoort

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Peru,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CogState Computerized Neurological Test Battery		Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98	No
Secondary	Neuropsychological Test Battery (NTB)		Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97	No
Secondary	Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog)		Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97	No
Secondary	Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)		Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97	No