Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00467766




Registration number
NCT00467766
Ethics application status
Date submitted
27/04/2007
Date registered
1/05/2007
Date last updated
7/05/2007

Titles & IDs
Public title
Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease
Scientific title
Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease
Secondary ID [1] 0 0
IA0114
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Caregivers 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Psychosocial information, counseling, and support
Treatment: Drugs - Donepezil (Aricept)

Behaviour: Psychosocial information, counseling, and support


Treatment: Drugs: Donepezil (Aricept)
Intervention code [1] 0 0
Behaviour
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Caregiver: Changes in depression, measured with the Beck Depression Inventory
Timepoint [1] 0 0
every 3 months for the first year, and every 6 months for the second year
Primary outcome [2] 0 0
Caregiver: Changes in social support satisfaction, measured with the Stokes Social Network Scale
Timepoint [2] 0 0
every 3 months for the first year, and every 6 months for the second year
Primary outcome [3] 0 0
Patient: Changes in cognition measured by ADAS-cog
Timepoint [3] 0 0
every 3 months for the first year, and every 6 months for the second year
Primary outcome [4] 0 0
Patient: Changes in abilities with activities of daily living measured by ADCS-ADL
Timepoint [4] 0 0
every 3 months for the first year, and every 6 months for the second year
Secondary outcome [1] 0 0
Caregiver: Changes in reactions to patient behavior, physical health, family conflict and sense of mastery
Timepoint [1] 0 0
every 3 months for the first year, and every 6 months for the second year
Secondary outcome [2] 0 0
Patient: Time to nursing home placement
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Individuals diagnosed with mild to moderate stage Alzheimer's disease and their spouse
caregivers
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe psychological or physical illness

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2003
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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?
Trial website
https://clinicaltrials.gov/ct2/show/NCT00467766
Trial related presentations / publications
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Mary S. Mittelman, DrPH
Address 0 0
NYU School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00467766