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

  Hide Study Locations
Locations
Sweden
Pfizer Investigational Site
Varnamo, 331 85, Sweden
Pfizer Investigational Site
135 21 Tyreso, Sweden
Pfizer Investigational Site
Akersberga, Sweden, 184 33 AKERSBERGA
Pfizer Investigational Site
Alunda, Sweden, 747 30
Pfizer Investigational Site
Aneby, Sweden, 578 21
Pfizer Investigational Site
Arsta, Sweden, 120 54
Pfizer Investigational Site
Avesta, Sweden, 774 82
Pfizer Investigational Site
Bengtsfors, Sweden, 666 30
Pfizer Investigational Site
Bergsjo, Sweden, 820 70
Pfizer Investigational Site
Boden, Sweden, 931 64
Pfizer Investigational Site
Borlange, Sweden, 781 27
Pfizer Investigational Site
Degerfors, Sweden, 693 22
Pfizer Investigational Site
Eskilstuna, Sweden, 632 23
Pfizer Investigational Site
Eskilstuna, Sweden, 631 88
Pfizer Investigational Site
Fritsla, Sweden, 510 29
Pfizer Investigational Site
Gislaved, Sweden, 332 30
Pfizer Investigational Site
Goteborg, Sweden, 412 75
Pfizer Investigational Site
Gullspang, Sweden, 547 31
Pfizer Investigational Site
Gustavsberg, Sweden, 134 30
Pfizer Investigational Site
Hedemora, Sweden, 776 28
Pfizer Investigational Site
Helsingborg, Sweden, 254 43
Pfizer Investigational Site
Ingelstad, Sweden, 360 44
Pfizer Investigational Site
Jönköping, Sweden, 553 16
Pfizer Investigational Site
Kalix, Sweden, 952 82
Pfizer Investigational Site
Karlstad, Sweden, 656 37
Pfizer Investigational Site
Katrineholm, Sweden, 641 47
Pfizer Investigational Site
Kristinehamn, Sweden, 681 29
Pfizer Investigational Site
Lidkoping, Sweden, 531 85
Pfizer Investigational Site
Malmo, Sweden, 205 02
Pfizer Investigational Site
Munkfors, Sweden, 684 23
Pfizer Investigational Site
Nassjo, Sweden, 576 81
Pfizer Investigational Site
Ostersund, Sweden, 831 31
Pfizer Investigational Site
Oxie, Sweden, 238 40
Pfizer Investigational Site
Partille, Sweden, 43323
Pfizer Investigational Site
Rattvik, Sweden, 795 21
Pfizer Investigational Site
Sandviken, Sweden, 811 60
Pfizer Investigational Site
Saro, Sweden, 429 13
Pfizer Investigational Site
Sjuntorp, Sweden, 460 20
Pfizer Investigational Site
Sollebrunn, Sweden, 466 30
Pfizer Investigational Site
Stockholm, Sweden, 116 32
Pfizer Investigational Site
Stockholm, Sweden, 112 35
Pfizer Investigational Site
Sunne, Sweden, 686 22
Pfizer Investigational Site
Trollhattan, Sweden, 461 59
Pfizer Investigational Site
Tullinge, Sweden, 146 31
Pfizer Investigational Site
Umeå, Sweden, 901 85
Pfizer Investigational Site
Unknown, Sweden
Pfizer Investigational Site
Upplands Väsby, Sweden, 194 04
Pfizer Investigational Site
Uppsala, Sweden, 751 25
Pfizer Investigational Site
Vaxjo, Sweden, 352 41
Pfizer Investigational Site
Visby, Sweden, 621 84
Pfizer Investigational Site
Vännäs, Sweden, 911 82
Pfizer Investigational Site
Västerås, Sweden, 722 11
Pfizer Investigational Site
Växjö, Sweden, 350 04
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
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 October 23, 2014