Multistimulation Group Therapy for Alzheimer's Disease
1 other identifier
interventional
60
1 country
1
Brief Summary
Our previous findings support the notion that group activity program, based on cognitive stimulation, recreational-occupational activities and physical-psychomotor exercises, can lead to an improvement in behavioral aspects for people with Alzheimer's Disease (AD). The purpose of this study is to clarify the efficacy of a rehabilitation program in outpatients affected by AD in mild to moderate stages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
July 9, 2013
CompletedJuly 9, 2013
June 1, 2013
2.9 years
June 24, 2013
July 2, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Change from baseline in behavioral level
Neuropsychiatric Inventory scale
Baseline, 10ws, 22ws
Change from baseline in cognitive level
ADAS cog scale
Baseline, 10ws, 22 ws
Change from baseline in quality of life
SF36 questionaire
baseline, 10ws,22 ws
Other Outcomes (1)
Functional MRI
baseline, 10 ws
Study Arms (2)
rehabilitation (MST) program
EXPERIMENTALThe Multidimensional Stimulation group therapy (MST) involved three levels of treatment. The first level was focused on PWA, the second level involved the caregiver, while the third one the dyad PWA-caregiver.
Usual care program
NO INTERVENTIONUsual care PWA program
Interventions
The MST program involved three levels of treatment. The first level was focused on PWA, the second level involved the caregiver, while the third one the dyad PWA-caregiver.
Eligibility Criteria
You may qualify if:
- diagnosis of possible/probable AD
- mild to moderate stage of AD (MMSE score of 15 - 24)and CDR score of 1-2
- range years in age (65-85) and in school attendance (5-17)
- right handed
You may not qualify if:
- severe aphasia (Token test score \< 20)
- severe auditory and/or visual loss
- overt severe behavioral disturbances (delusions, hallucinations, agitation)
- recent (three month before the MST) introduction or dose modification of the following pharmacological treatments: cholinesterase inhibitor, memantine, antidepressant or antipsychotic drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS, S Maria Nascente, FOndazione don Gnocchi
Milan, Italy
Related Publications (2)
Farina E, Mantovani F, Fioravanti R, Pignatti R, Chiavari L, Imbornone E, Olivotto F, Alberoni M, Mariani C, Nemni R. Evaluating two group programmes of cognitive training in mild-to-moderate AD: is there any difference between a 'global' stimulation and a 'cognitive-specific' one? Aging Ment Health. 2006 May;10(3):211-8. doi: 10.1080/13607860500409492.
PMID: 16777648BACKGROUNDFarina E, Fioravanti R, Chiavari L, Imbornone E, Alberoni M, Pomati S, Pinardi G, Pignatti R, Mariani C. Comparing two programs of cognitive training in Alzheimer's disease: a pilot study. Acta Neurol Scand. 2002 May;105(5):365-71. doi: 10.1034/j.1600-0404.2002.01086.x.
PMID: 11982487BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2013
First Posted
July 9, 2013
Study Start
January 1, 2010
Primary Completion
December 1, 2012
Last Updated
July 9, 2013
Record last verified: 2013-06