Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease

May 3, 2007 updated by: Pfizer
A unique multinational study was conducted simultaneously in the USA, England and Australia. The goals of the study were to answer two questions: Does psychosocial support for the family enhance the effectiveness of drug treatment for Alzheimer's disease? Is the added value of psychosocial support the same in all 3 countries?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a single-blind prospective randomized trial with 150 patient/caregiver pairs (50 in each country). Eligibility criteria at baseline require that the primary caregiver is the spouse of the patient; the patient must have a diagnosis of AD, be in the in mild to moderate stage of dementia, be living with the caregiver, and be willing to take Donepezil (Aricept). These participants were randomly assigned to one of two groups: in one group, the intervention consists of drug treatment for the patient plus psychosocial intervention for the caregiver; in the other group the intervention consists solely of drug treatment for the patient.

The intervention for the caregiver consists of 5 scheduled individual and family counseling sessions within 3 months of baseline, and unlimited consultations on request. Assessments were conducted every 3 months for the first year and every 6 months for a second year. There are 3 sources of data: an interview of the caregiver by an independent rater, an assessment of the patient, and a count of the amount of medication used. Thus we will be able to assess the effect of adding counseling to medication for the caregiver, for the patient, and on compliance with medication use.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

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

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
  • United Kingdom
      • Manchester, United Kingdom, M23 9LT
        • University of Manchester, Division of Psychiatry
  • United States
    • New York
      • New York, New York, United States, 10016
        • Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals diagnosed with mild to moderate stage Alzheimer's disease and their spouse caregivers

Exclusion Criteria:

  • Severe psychological or physical illness
  • Unwillingness by either spouse to participate in all aspects of the study

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: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Caregiver: Changes in depression, measured with the Beck Depression Inventory
Time Frame: every 3 months for the first year, and every 6 months for the second year
every 3 months for the first year, and every 6 months for the second year
Caregiver: Changes in social support satisfaction, measured with the Stokes Social Network Scale
Time Frame: every 3 months for the first year, and every 6 months for the second year
every 3 months for the first year, and every 6 months for the second year
Patient: Changes in cognition measured by ADAS-cog
Time Frame: every 3 months for the first year, and every 6 months for the second year
every 3 months for the first year, and every 6 months for the second year
Patient: Changes in abilities with activities of daily living measured by ADCS-ADL
Time Frame: every 3 months for the first year, and every 6 months for the second year
every 3 months for the first year, and every 6 months for the second year

Secondary Outcome Measures

Outcome Measure
Time Frame
Caregiver: Changes in reactions to patient behavior, physical health, family conflict and sense of mastery
Time Frame: every 3 months for the first year, and every 6 months for the second year
every 3 months for the first year, and every 6 months for the second year
Patient: Time to nursing home placement

Collaborators and Investigators

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

Sponsor

Pfizer

Investigators

  • Principal Investigator: Mary S. Mittelman, DrPH, NYU School of Medicine

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.

General Publications

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

July 1, 1999

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

April 27, 2007

First Submitted That Met QC Criteria

April 27, 2007

First Posted (Estimate)

May 1, 2007

Study Record Updates

Last Update Posted (Estimate)

May 7, 2007

Last Update Submitted That Met QC Criteria

May 3, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0114

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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