Multistimulation Group Therapy for Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

Multistimulation Group Therapy in Mild to Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893398
• Other study ID #: FdG_AD_01
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: July 2, 2013
• Start date: January 2010

Study information

• Verified date: June 2013
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS, S Maria Nascente, FOndazione don Gnocchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional MRI	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	No
Primary	Change from baseline in behavioral level	Neuropsychiatric Inventory scale	Baseline, 10ws, 22ws	No
Primary	Change from baseline in cognitive level	ADAS cog scale	Baseline, 10ws, 22 ws	No
Primary	Change from baseline in quality of life	SF36 questionaire	baseline, 10ws,22 ws	No

External Links

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