A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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
Outcome Measures for this Clinical Trial
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
- Time Frame: Month 6
- Change from baseline in Severe Impairment Battery (SIB) total score
- Time Frame: Month 6
Safety Issue?: No
- Time Frame: Month 6
Secondary Measures
- Change from baseline in SIB total score
- Time Frame: Month 3
Safety Issue?: No
- Time Frame: Month 3
- Change from baseline in Neuropsychiatric Inventory (NPI) total score
- Time Frame: Months 3 and 6
Safety Issue?: No
- Time Frame: Months 3 and 6
- Change from inclusion in Mini Mental State Examination (MMSE) total score
- Time Frame: Month 6
Safety Issue?: No
- Time Frame: Month 6
- Change from baseline in Clinical Global Impression of Improvement (CGI-I) score
- Time Frame: Months 3 and 6
Safety Issue?: No
- Time Frame: Months 3 and 6
- Adverse events and laboratory value changes
- Time Frame: Months 3 and 6
Safety Issue?: Yes
- Time Frame: Months 3 and 6
- Change from baseline in modified ADCS-ADL-severe total score
- Time Frame: Month 3
Safety Issue?: No
- Time Frame: Month 3
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00630851
