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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
Sponsor:
Information provided by:
Pfizer

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Donepezil (Aricept) Drug: Placebo Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Change from baseline in Severe Impairment Battery (SIB) total score [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Change from baseline in SIB total score [ Time Frame: Month 3 ]
  2. Change from baseline in Neuropsychiatric Inventory (NPI) total score [ Time Frame: Months 3 and 6 ]
  3. Change from inclusion in Mini Mental State Examination (MMSE) total score [ Time Frame: Month 6 ]
  4. Change from baseline in Clinical Global Impression of Improvement (CGI-I) score [ Time Frame: Months 3 and 6 ]
  5. Adverse events and laboratory value changes [ Time Frame: Months 3 and 6 ]
  6. Change from baseline in modified ADCS-ADL-severe total score [ Time Frame: Month 3 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


  Show 52 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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