A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00630851
First received: February 27, 2008
Last updated: March 4, 2015
Last verified: March 2015
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Purpose
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: Donepezil (Aricept) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome 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 ] [ Designated as safety issue: No ]
- Change from baseline in Severe Impairment Battery (SIB) total score [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in SIB total score [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
- Change from baseline in Neuropsychiatric Inventory (NPI) total score [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
- Change from inclusion in Mini Mental State Examination (MMSE) total score [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
- Change from baseline in Clinical Global Impression of Improvement (CGI-I) score [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
- Adverse events and laboratory value changes [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: Yes ]
- Change from baseline in modified ADCS-ADL-severe total score [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
| Enrollment: | 249 |
| Study Start Date: | October 2002 |
| Study Completion Date: | October 2004 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
|
| Placebo Comparator: 2 |
Drug: Placebo
Matching placebo tablets orally once daily for 6 months
|
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630851
Show 53 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630851
Show 53 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00630851 History of Changes |
| Other Study ID Numbers: | A2501017 |
| Study First Received: | February 27, 2008 |
| Last Updated: | March 4, 2015 |
| Health Authority: | Sweden: Medicinal Products Agency |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents |
ClinicalTrials.gov processed this record on September 29, 2016