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Multistimulation Group Therapy for Alzheimer's Disease

Multistimulation Group Therapy in Mild to Moderate Alzheimer's Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01893398
Enrollment
60
Registered
2013-07-09
Start date
2010-01-31
Completion date
Unknown
Last updated
2013-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

OTHERMultidimensional 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.

Sponsors

Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in behavioral levelBaseline, 10ws, 22wsNeuropsychiatric Inventory scale
Change from baseline in cognitive levelBaseline, 10ws, 22 wsADAS cog scale
Change from baseline in quality of lifebaseline, 10ws,22 wsSF36 questionaire

Other

MeasureTime frameDescription
Functional MRIbaseline, 10 wsChange 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026