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

NCT00467766 | Completed DMC

• 1 other identifier: IA0114
• Study Type: interventional
• Target: 300
• Locations: 3 countries
• Sites: 3

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?

Conditions

Alzheimer Disease; Caregivers

Keywords

dementia; Counseling

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Interventions

Psychosocial information, counseling, and support BEHAVIORAL

Donepezil (Aricept) DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

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

New York, New York, 10016, United States

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

University of Manchester, Division of Psychiatry

Manchester, M23 9LT, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 17101889 BACKGROUND

• 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.

  PMID: 15121650 BACKGROUND

• 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.

  PMID: 15197285 BACKGROUND

• 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.

  PMID: 16420138 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Counseling; Palliative Care; Donepezil

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Patient Care; Therapeutics; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Mary S. Mittelman, DrPH

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: May 1, 2007
• Study Start: July 1, 1999
• Study Completion: June 1, 2003
• Last Updated: May 7, 2007

Record last verified: 2007-05

Locations

US (1); AU (1); GB (1)