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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

5 mg capsule, orally, once daily, first 14 days of treatment

Donepezil

Intervention Type DRUG

10 mg, orally, once daily, for remaining 70 days of treatment

2

Group Type PLACEBO_COMPARATOR

Placebo to match Aricept

Intervention Type DRUG

Placebo capsule, orally, 84 days of treatment

Interventions

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Donepezil

5 mg capsule, orally, once daily, first 14 days of treatment

Intervention Type DRUG

Donepezil

10 mg, orally, once daily, for remaining 70 days of treatment

Intervention Type DRUG

Placebo to match Aricept

Placebo capsule, orally, 84 days of treatment

Intervention Type DRUG

Other Intervention Names

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Aricept Aricept

Eligibility 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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

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

Site Status

Research Site

Gatineau, Quebec, Canada

Site Status

Research Site

Montreal, Quebec, Canada

Site Status

Research Site

Québec, Quebec, Canada

Site Status

Reearch Site

Québec, , Canada

Site Status

Research Site

Callao, Lima, Peru

Site Status

Research Site

Callao, , Peru

Site Status

Research Site

Lima, , Peru

Site Status

Research Site

Chojnice, , Poland

Site Status

Research Site

Gdansk, , Poland

Site Status

Research Site

Kalisz, , Poland

Site Status

Research Site

Piła, , Poland

Site Status

Research Site

Poznan, , Poland

Site Status

Research Site

Sopot, , Poland

Site Status

Research Site

Ścinawa, , Poland

Site Status

Research Site

Warsaw, , Poland

Site Status

Research Site

Cape Town, Western Cape, South Africa

Site Status

Research Site

Roodepoort, , South Africa

Site Status

Countries

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Canada Peru Poland South Africa

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.

Reference Type DERIVED
PMID: 23763450 (View on PubMed)

Other Identifiers

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D2285M00010

Identifier Type: -

Identifier Source: org_study_id

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