The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
NCT ID: NCT01024660
Last Updated: 2011-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
155 participants
INTERVENTIONAL
2009-12-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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1
5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)
Donepezil
5 mg capsule, orally, once daily, first 14 days of treatment
Donepezil
10 mg, orally, once daily, for remaining 70 days of treatment
2
Placebo to match Aricept
Placebo capsule, orally, 84 days of treatment
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* Females of child bearing potential
* Impaired vision or hearing
55 Years
85 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Malene Jensen
Role: STUDY_DIRECTOR
Study Delievery Director, AstraZeneca
Locations
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Research Site
Ottawa, Ontario, Canada
Research Site
Gatineau, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Reearch Site
Québec, , Canada
Research Site
Callao, Lima, Peru
Research Site
Callao, , Peru
Research Site
Lima, , Peru
Research Site
Chojnice, , Poland
Research Site
Gdansk, , Poland
Research Site
Kalisz, , Poland
Research Site
Piła, , Poland
Research Site
Poznan, , Poland
Research Site
Sopot, , Poland
Research Site
Ścinawa, , Poland
Research Site
Warsaw, , Poland
Research Site
Cape Town, Western Cape, South Africa
Research Site
Roodepoort, , South Africa
Countries
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References
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Karin A, Hannesdottir K, Jaeger J, Annas P, Segerdahl M, Karlsson P, Sjogren 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.
Other Identifiers
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D2285M00010
Identifier Type: -
Identifier Source: org_study_id
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