A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes - Full Text View

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Nursing Homes

Drug Information available for: Donepezil hydrochloride Donepezil

Genetic and Rare Diseases Information Center resources: Alzheimer Disease Familial

U.S. FDA Resources

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
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

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided


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:	April 22, 2011
Health Authority:	Sweden: Medicinal Products Agency

Additional relevant MeSH terms:


Alzheimer Disease Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies Donepezil	Central Nervous System Agents Cholinergic Agents Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Nootropic Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015