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

Primary Purpose

Alzheimer Disease, Caregivers

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Psychosocial information, counseling, and support

Donepezil (Aricept)

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring dementia, Counseling

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine
Prince of Wales Hospital
University of Manchester, Division of Psychiatry

Outcomes

Primary Outcome Measures

Caregiver: Changes in depression, measured with the Beck Depression Inventory

Caregiver: Changes in social support satisfaction, measured with the Stokes Social Network Scale

Patient: Changes in cognition measured by ADAS-cog

Patient: Changes in abilities with activities of daily living measured by ADCS-ADL

Secondary Outcome Measures

Caregiver: Changes in reactions to patient behavior, physical health, family conflict and sense of mastery

Patient: Time to nursing home placement

Full Information

NCT ID

NCT00467766

First Posted

April 27, 2007

Last Updated

May 3, 2007

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00467766

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Completed

Study Start Date

July 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Caregivers

Keywords

dementia, Counseling

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Psychosocial information, counseling, and support

Intervention Type

Drug

Intervention Name(s)

Donepezil (Aricept)

Primary Outcome Measure Information:

Title

Caregiver: Changes in depression, measured with the Beck Depression Inventory

Time Frame