Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-27 @ 10:41 AM
Study NCT ID:
NCT00467766
Status:
COMPLETED
Last Update Posted:
2007-05-07
First Post:
2007-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-03', 'studyFirstSubmitDate': '2007-04-27', 'studyFirstSubmitQcDate': '2007-04-27', 'lastUpdatePostDateStruct': {'date': '2007-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caregiver: Changes in depression, measured with the Beck Depression Inventory', 'timeFrame': 'every 3 months for the first year, and every 6 months for the second year'}, {'measure': 'Caregiver: Changes in social support satisfaction, measured with the Stokes Social Network Scale', 'timeFrame': 'every 3 months for the first year, and every 6 months for the second year'}, {'measure': 'Patient: Changes in cognition measured by ADAS-cog', 'timeFrame': 'every 3 months for the first year, and every 6 months for the second year'}, {'measure': 'Patient: Changes in abilities with activities of daily living measured by ADCS-ADL', 'timeFrame': 'every 3 months for the first year, and every 6 months for the second year'}], 'secondaryOutcomes': [{'measure': 'Caregiver: Changes in reactions to patient behavior, physical health, family conflict and sense of mastery', 'timeFrame': 'every 3 months for the first year, and every 6 months for the second year'}, {'measure': 'Patient: Time to nursing home placement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dementia', 'Counseling'], 'conditions': ['Alzheimer Disease', 'Caregivers']}, 'referencesModule': {'references': [{'pmid': '17101889', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15121650', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '15197285', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16420138', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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?", 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals diagnosed with mild to moderate stage Alzheimer's disease and their spouse caregivers\n\nExclusion Criteria:\n\n* Severe psychological or physical illness\n* Unwillingness by either spouse to participate in all aspects of the study"}, 'identificationModule': {'nctId': 'NCT00467766', 'briefTitle': "Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease", 'organization': {'class': 'NIH', 'fullName': 'National Institute on Aging (NIA)'}, 'officialTitle': "Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'IA0114'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Psychosocial information, counseling, and support', 'type': 'BEHAVIORAL'}, {'name': 'Donepezil (Aricept)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'University of Manchester, Division of Psychiatry', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Mary S. Mittelman, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}