A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
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ClinicalTrials.gov Identifier: NCT00630851 |
Recruitment Status
:
Completed
First Posted
: March 7, 2008
Last Update Posted
: March 5, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Drug: Donepezil (Aricept) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 249 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | October 2002 |
Actual Study Completion Date : | October 2004 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- Change from baseline in Severe Impairment Battery (SIB) total score [ Time Frame: Month 6 ]
- Change from baseline in SIB total score [ Time Frame: Month 3 ]
- Change from baseline in Neuropsychiatric Inventory (NPI) total score [ Time Frame: Months 3 and 6 ]
- Change from inclusion in Mini Mental State Examination (MMSE) total score [ Time Frame: Month 6 ]
- Change from baseline in Clinical Global Impression of Improvement (CGI-I) score [ Time Frame: Months 3 and 6 ]
- Adverse events and laboratory value changes [ Time Frame: Months 3 and 6 ]
- Change from baseline in modified ADCS-ADL-severe total score [ Time Frame: Month 3 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630851

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00630851 History of Changes |
Other Study ID Numbers: |
A2501017 |
First Posted: | March 7, 2008 Key Record Dates |
Last Update Posted: | March 5, 2015 |
Last Verified: | March 2015 |
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 |