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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00480220 |
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Date of registration:
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29/05/2007 |
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Primary sponsor: |
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Public title:
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Specific Care and Assistance Plan for Alzheimer's Disease
PLASA |
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Scientific title:
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Specific Care and Assistance Plan for Alzheimer's Disease: Impact Study on Disease Progression and Management Modalities |
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Date of first enrolment:
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August 2003 |
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Target sample size:
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1200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00480220 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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France
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Contacts
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Name:
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VELLAS Bruno, PU-PH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patient seen in consultation in one of the centres participating in the study
- aged over 65 years
- patient with probable or possible AD according to NINCDS-ADRDA criteria
- patient with an MMSE score between 12 and 26 (mild to moderate disease)
- patient capable of understanding and responding to the evaluations made
- patient who is not confined to bed or chair
- patient living at home with an informal caregiver
- informed consent of the patient (or legal representative) and of the caregiver
agreeing to take part in the study.
Exclusion Criteria:
- patient aged less than 65 years
- patient with an MMSE score of less than 12 or over 26
- patient incapable of understanding and responding to the evaluations made
- patient confined to bed or chair
- patient living at home without an informal carer or in an institution
- patient with a concomitant disorder threatening the vital prognosis at two years
- patient with a dementia other than AD
- patient already included in another research programme.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Intervention(s)
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Other: No specific intervention
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Procedure: Global care and support program
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Primary Outcome(s)
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Evaluate the efficacy of the specific care and assistance plan for Alzheimer's disease in a study randomised within each centre. The main aim of the care plan is to reduce loss of independence.
[Time Frame: 2 years]
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Secondary Outcome(s)
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Impact of the care and assistance plan: - on the mode of the patient's admission to an institution - on utilization of assistance, support and healthcare services (RUD questionnaire) - and on overall clinical evaluation of change (ADCS-CGIC).
[Time Frame: 2 years]
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Secondary ID(s)
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0200601
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PHRC 2001 and PHRC 2006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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