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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01024660 |
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Date of registration:
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02/12/2009 |
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Primary sponsor: |
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Public title:
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The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
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Scientific title:
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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 |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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155 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01024660 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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Countries of recruitment
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Canada
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Peru
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Poland
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South Africa
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Contacts
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Name:
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Malene Jensen |
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Address:
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Telephone:
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Email:
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Affiliation:
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Study Delievery Director, AstraZeneca |
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Key inclusion & exclusion criteria
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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
Age minimum:
55 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Intervention(s)
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Drug: Donepezil
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Drug: Placebo to match Aricept
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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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]
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Secondary ID(s)
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D2285M00010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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