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

NCT ID: NCT00467766

Last Updated: 2007-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2003-06-30

Brief Summary

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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

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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

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Alzheimer Disease Caregivers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Psychosocial information, counseling, and support

Intervention Type BEHAVIORAL

Donepezil (Aricept)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Mary S. Mittelman, DrPH

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine

New York, New York, United States

Site Status

Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status

University of Manchester, Division of Psychiatry

Manchester, , United Kingdom

Site Status

Countries

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United States Australia United Kingdom

References

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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. doi: 10.1212/01.wnl.0000242727.81172.91.

Reference Type BACKGROUND
PMID: 17101889 (View on PubMed)

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. doi: 10.1176/appi.ajp.161.5.850.

Reference Type BACKGROUND
PMID: 15121650 (View on PubMed)

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. doi: 10.1093/geront/44.3.311.

Reference Type BACKGROUND
PMID: 15197285 (View on PubMed)

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. doi: 10.1037/0882-7974.20.4.634.

Reference Type BACKGROUND
PMID: 16420138 (View on PubMed)

Other Identifiers

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IA0114

Identifier Type: -

Identifier Source: org_study_id