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

Not Applicable

Completed

• Conditions: Alzheimer Disease; Caregivers

• Registration Number: NCT00467766
• Lead Sponsor: Pfizer

Brief Summary

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?

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 Timeline

• Study Start: 1999-07
• Study Completion: 2003-06
• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-27
• Status Verified: 2007-05
• Study First Posted: 2007-05-01
• Last Update Submitted: 2007-05-03
• Last Update Posted: 2007-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Caregiver: Changes in depression, measured with the Beck Depression Inventory	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	every 3 months for the first year, and every 6 months for the second year
Patient: Changes in cognition measured by ADAS-cog	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	every 3 months for the first year, and every 6 months for the second year

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine; 🇺🇸 New York, New York, United States

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

University of Manchester, Division of Psychiatry; 🇬🇧 Manchester, United Kingdom