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

March 4, 2015 updated by: Pfizer

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

The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Sweden
      • 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, 631 88
        • Pfizer Investigational Site
      • Eskilstuna, Sweden, 632 23
        • 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, 112 35
        • Pfizer Investigational Site
      • Stockholm, Sweden, 116 32
        • Pfizer Investigational Site
      • Sunne, Sweden, 686 22
        • Pfizer Investigational Site
      • Trollhattan, Sweden, 461 59
        • Pfizer Investigational Site
      • Tullinge, Sweden, 146 31
        • Pfizer Investigational Site
      • Tyreso, Sweden, 13521
        • Pfizer Investigational Site
      • Umeå, Sweden, 901 85
        • Pfizer Investigational Site
      • Upplands Väsby, Sweden, 194 04
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 25
        • Pfizer Investigational Site
      • Varnamo, Sweden, 33185
        • 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
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Month 6
Change from baseline in Severe Impairment Battery (SIB) total score
Time Frame: Month 6
Month 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2501017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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