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Completed

NCT Number: NCT01893398

Multistimulation Group Therapy for 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS, S Maria Nascente, FOndazione don Gnocchi

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multidimensional stimulation group therapy

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Multistimulation Group Therapy in Mild to Moderate Alzheimer's Disease

Important dates

Study start
2010
Primary completion
2012
First posted
Jul 9, 2013
Registry last updated
Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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