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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine
New York, New York, 10016 United States
Contact
1-800-718-1021
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

NCT00467766
Pfizer
Completed
Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer’s Disease

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
  • Alzheimer Disease
  • Caregivers
  • Behavioral: Psychosocial information, counseling, and support
  • Drug: Donepezil (Aricept)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
June 2003
Not Provided

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United Kingdom,   United States
 
 
NCT00467766
IA0114
Yes
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Principal Investigator: Mary S. Mittelman, DrPH NYU School of Medicine
National Institute on Aging (NIA)
May 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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