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

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NCT00467766

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Study Location
Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine
New York, New York, 10016, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease, Caregivers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Individuals diagnosed with mild to moderate stage Alzheimer’s disease and their spouse caregivers

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Severe psychological or physical illness


- Unwillingness by either spouse to participate in all aspects of the study

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Alzheimer Disease, CaregiversCombining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer’s Disease NCT00467766
  1. New York, New York
  2. Randwick, New South Wales
  3. Manchester,
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
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, DrPHNYU 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