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

NCT ID: NCT00630851

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Donepezil (Aricept)

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo tablets orally once daily for 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Placebo

Matching placebo tablets orally once daily for 6 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Fritsla, Sweden, Sweden

Site Status

Pfizer Investigational Site

Alunda, , Sweden

Site Status

Pfizer Investigational Site

Aneby, , Sweden

Site Status

Pfizer Investigational Site

Avesta, , Sweden

Site Status

Pfizer Investigational Site

Åkersberga, , Sweden

Site Status

Pfizer Investigational Site

Årsta, , Sweden

Site Status

Pfizer Investigational Site

Bengtsfors, , Sweden

Site Status

Pfizer Investigational Site

Bergsjö, , Sweden

Site Status

Pfizer Investigational Site

Boden, , Sweden

Site Status

Pfizer Investigational Site

Borlänge, , Sweden

Site Status

Pfizer Investigational Site

Degerfors, , Sweden

Site Status

Pfizer Investigational Site

Eskilstuna, , Sweden

Site Status

Pfizer Investigational Site

Eskilstuna, , Sweden

Site Status

Pfizer Investigational Site

Gislaved, , Sweden

Site Status

Pfizer Investigational Site

Gothenburg, , Sweden

Site Status

Pfizer Investigational Site

Gullspång, , Sweden

Site Status

Pfizer Investigational Site

Gustavsberg, , Sweden

Site Status

Pfizer Investigational Site

Hedemora, , Sweden

Site Status

Pfizer Investigational Site

Helsingborg, , Sweden

Site Status

Pfizer Investigational Site

Ingelstad, , Sweden

Site Status

Pfizer Investigational Site

Jönköping, , Sweden

Site Status

Pfizer Investigational Site

Kalix, , Sweden

Site Status

Pfizer Investigational Site

Karlstad, , Sweden

Site Status

Pfizer Investigational Site

Katrineholm, , Sweden

Site Status

Pfizer Investigational Site

Kristinehamn, , Sweden

Site Status

Pfizer Investigational Site

Lidköping, , Sweden

Site Status

Pfizer Investigational Site

Malmo, , Sweden

Site Status

Pfizer Investigational Site

Munkfors, , Sweden

Site Status

Pfizer Investigational Site

Nässjö, , Sweden

Site Status

Pfizer Investigational Site

Oxie, , Sweden

Site Status

Pfizer Investigational Site

Östersund, , Sweden

Site Status

Pfizer Investigational Site

Partille, , Sweden

Site Status

Pfizer Investigational Site

Rättvik, , Sweden

Site Status

Pfizer Investigational Site

Sandviken, , Sweden

Site Status

Pfizer Investigational Site

Särö, , Sweden

Site Status

Pfizer Investigational Site

Sjuntorp, , Sweden

Site Status

Pfizer Investigational Site

Sollebrunn, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Sunne, , Sweden

Site Status

Pfizer Investigational Site

Trollhättan, , Sweden

Site Status

Pfizer Investigational Site

Tullinge, , Sweden

Site Status

Pfizer Investigational Site

Tyreso, , Sweden

Site Status

Pfizer Investigational Site

Umeå, , Sweden

Site Status

Pfizer Investigational Site

Upplands Vasby, , Sweden

Site Status

Pfizer Investigational Site

Uppsala, , Sweden

Site Status

Pfizer Investigational Site

Vaxjo, , Sweden

Site Status

Pfizer Investigational Site

Vaxjo, , Sweden

Site Status

Pfizer Investigational Site

Vännäs, , Sweden

Site Status

Pfizer Investigational Site

Värnamo, , Sweden

Site Status

Pfizer Investigational Site

Västerås, , Sweden

Site Status

Pfizer Investigational Site

Visby, , Sweden

Site Status

Pfizer Investigational Site

, ,

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A2501017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.