Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Fondazione Don Carlo Gnocchi Onlus

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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Multidimensional stimulation group therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline in behavioral level [ Time Frame: Baseline, 10ws, 22ws ]
    Neuropsychiatric Inventory scale

  2. Change from baseline in cognitive level [ Time Frame: Baseline, 10ws, 22 ws ]
    ADAS cog scale

  3. Change from baseline in quality of life [ Time Frame: baseline, 10ws,22 ws ]
    SF36 questionaire


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Italy
IRCCS, S Maria Nascente, FOndazione don Gnocchi
Milan, Italy
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT01893398     History of Changes
Other Study ID Numbers: FdG_AD_01
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders