Official Title: “A Six-Month, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effect on Global/Behavioural/ADL Functions and Tolerability of Aricept in Patients Wtih Severe Alzheimer's Disease Living in an Assisted Care Facility”

The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Donepezil (Aricept)
  • Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment
• Drug: Placebo
  • Matching placebo tablets orally once daily for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score
  • Time Frame: Month 6
    Safety Issue?: No
• Change from baseline in Severe Impairment Battery (SIB) total score
  • Time Frame: Month 6
    Safety Issue?: No

Secondary Measures

• Change from baseline in SIB total score
  • Time Frame: Month 3
    Safety Issue?: No
• Change from baseline in Neuropsychiatric Inventory (NPI) total score
  • Time Frame: Months 3 and 6
    Safety Issue?: No
• Change from inclusion in Mini Mental State Examination (MMSE) total score
  • Time Frame: Month 6
    Safety Issue?: No
• Change from baseline in Clinical Global Impression of Improvement (CGI-I) score
  • Time Frame: Months 3 and 6
    Safety Issue?: No
• Adverse events and laboratory value changes
  • Time Frame: Months 3 and 6
    Safety Issue?: Yes
• Change from baseline in modified ADCS-ADL-severe total score
  • Time Frame: Month 3
    Safety Issue?: No

Inclusion Criteria:

• Probable or possible Alzheimer's disease
• Living in skilled nursing home

Exclusion Criteria:

• Other types of dementia or psychiatric or neurologic disorders
• Musculoskeletal disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00630851

Study ID Number: A2501017

ClinicalTrials.gov Identifier: NCT00630851

Health Authority: Sweden: Medicinal Products Agency

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Link to ClinicalStudyResults.org Posting