Alzheimer DiseaseNCT00467766
Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease
A study testing Psychosocial information, counseling, and support and Donepezil (Aricept) in people with Alzheimer Disease and Caregivers, run by Pfizer at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alzheimer Disease, Caregivers
- What is being tested?
- Psychosocial information, counseling, and support and Donepezil (Aricept)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 1999to Jun 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with mild to moderate stage Alzheimer's disease and their spouse caregivers
Who cannot join
- Severe psychological or physical illness
- Unwillingness by either spouse to participate in all aspects of the study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine
New York, New York, 10016
United Kingdom1 site
University of Manchester, Division of Psychiatry
Manchester, M23 9LT
About this study
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?
Read the 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.
- Conditions
- Alzheimer Disease, Caregivers
- Being tested
- Psychosocial information, counseling, and support, Donepezil (Aricept)
- Keywords
- dementia, Counseling
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial information, counseling, and supportBehavioural
Donepezil (Aricept)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver: Changes in depression, measured with the Beck Depression Inventory
Measured: 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
Measured: every 3 months for the first year, and every 6 months for the second year
Patient: Changes in cognition measured by ADAS-cog
Measured: 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
Measured: 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
Measured: every 3 months for the first year, and every 6 months for the second year
Patient: Time to nursing home placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
- Study startJul 1999
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mary S. Mittelman, DrPH, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467766
- Sponsor's protocol ID
- IA0114
- Status last verified
- May 2007
- First submitted
- 27 Apr 2007
- Last updated
- 7 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17101889Mittelman 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.
PubMed 15121650Jang 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.
PubMed 15197285Roth 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.
PubMed 16420138
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00467766
- Acronym / sponsor ID
- IA0114
- Conditions
- Alzheimer Disease, Caregivers
- Keywords
- dementia, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 1999
- Study completion
- Jun 2003 (actual)
- First posted
- 1 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals diagnosed with mild to moderate stage Alzheimer's disease and their spouse caregivers
Key exclusion criteria (2 listed)
- Severe psychological or physical illness
- Unwillingness by either spouse to participate in all aspects of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial information, counseling, and support | Behavioural | – |
| Donepezil (Aricept) | Drug | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2007.
- Background: PubMed 17101889Mittelman 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.
- Background: PubMed 15121650Mittelman 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.
- Background: PubMed 15197285Jang 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.
- Background: PubMed 16420138Roth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary S. Mittelman, DrPH principal investigator
NYU School of Medicine
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial information, counseling, and support and Donepezil (Aricept) in people with Alzheimer Disease and Caregivers, run by Pfizer at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00467766, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2007.