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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01024660
Collaborator
(none)
155
Enrollment
18
Locations
2
Arms
13
Duration (Months)
8.6
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2009
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

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 Names:
  • Aricept

    • Drug: Donepezil
    10 mg, orally, once daily, for remaining 70 days of treatment
    Other Names:
  • Aricept

    		•
    Placebo Comparator: 2

    Drug: Placebo to match Aricept
    Placebo capsule, orally, 84 days of treatment

    Outcome Measures

    Primary Outcome Measures

    1. CogState Computerized Neurological Test Battery [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) [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) [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) [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

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Ottawa Ontario Canada
    2 Research Site Gatineau Quebec Canada
    3 Research Site Montreal Quebec Canada
    4 Reearch Site Quebec Canada
    5 Research Site Quebec Canada
    6 Research Site Callao Lima Peru
    7 Research Site Callao Peru
    8 Research Site Lima Peru
    9 Research Site Chojnice Poland
    10 Research Site Gdansk Poland
    11 Research Site Kalisz Poland
    12 Research Site Pila Poland
    13 Research Site Poznan Poland
    14 Research Site Scinawa Poland
    15 Research Site Sopot Poland
    16 Research Site Warszawa Poland
    17 Research Site Cape Town Western Cape South Africa
    18 Research Site Roodepoort South Africa

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Malene Jensen, Study Delievery Director, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01024660
    Other Study ID Numbers:
    • D2285M00010
    First Posted:
    Dec 3, 2009
    Last Update Posted:
    Feb 8, 2011
    Last Verified:
    Feb 1, 2011
    Keywords provided by , ,
    Patients with Mild to Moderate Alzheimer's Disease
    Additional relevant MeSH terms:
    Alzheimer Disease
    Donepezil

    Study Results

    No Results Posted as of Feb 8, 2011