Multistimulation Group Therapy for Alzheimer's Disease
|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 evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01893398|
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : July 9, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Other: Multidimensional stimulation group therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Multistimulation Group Therapy in Mild to Moderate Alzheimer's Disease|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2012|
Experimental: rehabilitation (MST) program
The 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.
Other: Multidimensional stimulation group therapy
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.
No Intervention: Usual care program
Usual care PWA program
- Change from baseline in behavioral level [ Time Frame: Baseline, 10ws, 22ws ]Neuropsychiatric Inventory scale
- Change from baseline in cognitive level [ Time Frame: Baseline, 10ws, 22 ws ]ADAS cog scale
- Change from baseline in quality of life [ Time Frame: baseline, 10ws,22 ws ]SF36 questionaire
- Functional MRI [ Time Frame: baseline, 10 ws ]Change from baseline in brain functioning. We used fMRI with cognitive task to detect possible changes (10 ws versus baseline) in brain activation patterns in PWA as a surrogate biomarker of efficacy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893398
|IRCCS, S Maria Nascente, FOndazione don Gnocchi|