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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: Donepezil
Drug: Placebo to match Aricept
 Phase 0

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 155
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024660

Locations
Canada, Ontario
Research Site
Ottawa, Ontario, Canada
Canada, Quebec
Research Site
Gatineau, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Canada
Reearch Site
Quebec, Canada
Research Site
Quebec, Canada
Peru
Research Site
Callao, Lima, Peru
Research Site
Callao, Peru
Research Site
Lima, Peru
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, Poland
South Africa
Research Site
Cape Town, Western Cape, South Africa
Research Site
Roodepoort, South Africa
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Malene Jensen Study Delievery Director, AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01024660     History of Changes
Other Study ID Numbers: D2285M00010
Study First Received: December 2, 2009
Last Updated: February 6, 2011
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Instituto Nacional de Salud
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council

Keywords provided by AstraZeneca:
Patients with Mild to Moderate Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013