NCT00467766

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease
• Caregivers

Interventions

Type	Name	Description
BEHAVIORAL	Psychosocial information, counseling, and support
DRUG	Donepezil (Aricept)

Timeline

• Start date: 1999-07-01
• Completion: 2003-06-01
• First posted: 2007-05-01
• Last updated: 2007-05-07

Locations

3 sites across 3 countries: United States, Australia, United Kingdom