Multistimulation Group Therapy for Alzheimer's Disease

July 2, 2013 updated by: Fondazione Don Carlo Gnocchi Onlus

Multistimulation Group Therapy in Mild to Moderate Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • IRCCS, S Maria Nascente, FOndazione don Gnocchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in behavioral level
Time Frame: Baseline, 10ws, 22ws
Neuropsychiatric Inventory scale
Baseline, 10ws, 22ws
Change from baseline in cognitive level
Time Frame: Baseline, 10ws, 22 ws
ADAS cog scale
Baseline, 10ws, 22 ws
Change from baseline in quality of life
Time Frame: baseline, 10ws,22 ws
SF36 questionaire
baseline, 10ws,22 ws

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 10 ws

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 9, 2013

Study Record Updates

Last Update Posted (Estimate)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 2, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FdG_AD_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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