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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01024660
First received: December 2, 2009
Last updated: February 6, 2011
Last verified: February 2011

December 2, 2009
February 6, 2011
December 2009
January 2011   (final data collection date for primary outcome measure)
CogState Computerized Neurological Test Battery [ Time Frame: 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 ] [ Designated as safety issue: No ]
CogState Test Battery [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01024660 on ClinicalTrials.gov Archive Site
  • Neuropsychological Test Battery (NTB) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Neuropsychological Test Battery (NTB) [ Designated as safety issue: No ]
  • Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) [ Designated as safety issue: No ]
  • Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
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

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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Alzheimer's Disease
  • 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
  • Drug: Placebo to match Aricept
    Placebo capsule, orally, 84 days of treatment
  • Active Comparator: 1
    5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)
    Interventions:
    • Drug: Donepezil
    • Drug: Donepezil
  • Placebo Comparator: 2
    Intervention: Drug: Placebo to match Aricept
Karin A, Hannesdottir K, Jaeger J, Annas P, Segerdahl M, Karlsson P, Sjögren N, von Rosen T, Miller F. Psychometric evaluation of ADAS-Cog and NTB for measuring drug response. Acta Neurol Scand. 2014 Feb;129(2):114-22. doi: 10.1111/ane.12153. Epub 2013 Jun 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Peru,   South Africa,   Poland
 
NCT01024660
D2285M00010
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Malene Jensen Study Delievery Director, AstraZeneca
AstraZeneca
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP