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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01024660
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : February 8, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Donepezil Drug: Placebo to match Aricept Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024660


Locations
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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
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Study Director: Malene Jensen Study Delievery Director, AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01024660    
Other Study ID Numbers: D2285M00010
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: February 2011
Keywords provided by AstraZeneca:
Patients with Mild to Moderate Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents