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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467766
• Other study ID #: IA0114
• Status: Completed
• Phase: N/A
• First received: April 27, 2007
• Last updated: May 3, 2007
• Start date: July 1999
• Est. completion date: June 2003

Study information

• Verified date: May 2007
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregivers

Intervention

Behavioral:
• Psychosocial information, counseling, and support

Drug:
• Donepezil (Aricept)

Locations

Country	Name	City	State
Australia	Prince of Wales Hospital	Randwick	New South Wales
United Kingdom	University of Manchester, Division of Psychiatry	Manchester
United States	Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

References & Publications (4)

Jang Y, Clay OJ, Roth DL, Haley WE, Mittelman MS. Neuroticism and longitudinal change in caregiver depression: impact of a spouse-caregiver intervention program. Gerontologist. 2004 Jun;44(3):311-7. — View Citation

Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease. Neurology. 2006 Nov 14;67(9):1592-9. — View Citation

Mittelman MS, Roth DL, Coon DW, Haley WE. Sustained benefit of supportive intervention for depressive symptoms in caregivers of patients with Alzheimer's disease. Am J Psychiatry. 2004 May;161(5):850-6. — View Citation

Roth DL, Mittelman MS, Clay OJ, Madan A, Haley WE. Changes in social support as mediators of the impact of a psychosocial intervention for spouse caregivers of persons with Alzheimer's disease. Psychol Aging. 2005 Dec;20(4):634-44. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Patient: Changes in cognition measured by ADAS-cog		every 3 months for the first year, and every 6 months for the second year
Primary	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	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
Secondary	Patient: Time to nursing home placement