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Trial record 1 of 1 for:    NCT00467766
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Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer’s Disease

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ClinicalTrials.gov Identifier: NCT00467766
Recruitment Status : Completed
First Posted : May 1, 2007
Last Update Posted : May 7, 2007
Sponsor:
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE April 27, 2007
First Posted Date  ICMJE May 1, 2007
Last Update Posted Date May 7, 2007
Study Start Date  ICMJE July 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • Caregiver: Changes in depression, measured with the Beck Depression Inventory [ Time Frame: 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 [ Time Frame: every 3 months for the first year, and every 6 months for the second year ]
  • Patient: Changes in cognition measured by ADAS-cog [ Time Frame: 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 [ Time Frame: every 3 months for the first year, and every 6 months for the second year ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00467766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • Caregiver: Changes in reactions to patient behavior, physical health, family conflict and sense of mastery [ Time Frame: every 3 months for the first year, and every 6 months for the second year ]
  • Patient: Time to nursing home placement
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer’s Disease
Official Title  ICMJE Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer’s Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Caregivers
Intervention  ICMJE
  • Behavioral: Psychosocial information, counseling, and support
  • Drug: Donepezil (Aricept)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2007)
300
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00467766
Other Study ID Numbers  ICMJE IA0114
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary S. Mittelman, DrPH NYU School of Medicine
PRS Account National Institute on Aging (NIA)
Verification Date May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP