Multistimulation Group Therapy for Alzheimer's Disease

NCT ID: NCT01893398

Last Updated: 2013-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Multidimensional stimulation group therapy

Intervention Type OTHER

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.

Usual care program

Usual care PWA program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS, S Maria Nascente, FOndazione don Gnocchi

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 16777648 (View on PubMed)

Farina 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.

Reference Type BACKGROUND
PMID: 11982487 (View on PubMed)

Related Links

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Other Identifiers

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FdG_AD_01

Identifier Type: -

Identifier Source: org_study_id

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