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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00630851
First received: February 27, 2008
Last updated: April 22, 2011
Last verified: April 2011
  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
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:
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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014