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Clinical Trials/NCT02020356
NCT02020356
Terminated
N/A

Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.

University Hospital, Toulouse7 sites in 1 country35 target enrollmentApril 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer's Type Dementia
Sponsor
University Hospital, Toulouse
Enrollment
35
Locations
7
Primary Endpoint
Neuroleptic reduction dose
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

The primary purpose of the protocol is to demonstrate that the use of music therapy may make it possible to discontinue at least one of neuroleptic treatment in patients with AD or related symptoms complicated by behavioral disorders such as agitation and aggressiveness evaluated using the Neuropsychiatric Inventory (NPI).

The study hypothesis is that music therapy may have a positive impact on patients with AD complicated by behavioral disorders by reducing the intensity of oppositional behaviour and aggressiveness and allowing a diminution of neuroleptic treatment.

Detailed Description

A technique of receptive music therapy to induce relaxation has been developed in the university hospital of Montpellier: the "U" sequence. The musical sequence lasts 20 minutes and is made up of several phases that progressively induce a relaxed state in the patient. This effect is obtained by modulating the rhythm of the music, the orchestral formation, frequencies and volume. The phase of maximum relaxation is followed by a stimulating phase. These musical sequences have been specially designed by the music publishers Music Care©.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
June 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects of either sex aged 65 years and over, living in an institution for the dependent elderly for at least 3 months
  • Subjects with Alzheimer-type dementia (DSM-IV and National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria)or related symptoms
  • If treated, Treated for at least 6 months with a stable dose of cholinesterase inhibitor or memantine
  • Mini-Mental State Examination (MMSE) score between 5 and 20
  • Patients with disruptive behaviour (at least one disruptive item on the NPI: oppositional behaviour/aggressiveness/agitation, aberrant motor behaviour, with a severity score grater than or equal to 4) and treated with at least one neuroleptic whose dose which could not be decreased because of persistence of the behavioural problems for at least 15 days.

Exclusion Criteria

  • Decompensated physical disease
  • Inability to give informed consent
  • Lack of health insurance coverage
  • Non-corrected hearing impairment
  • treatment ongoing with two or more neuroleptics

Outcomes

Primary Outcomes

Neuroleptic reduction dose

Time Frame: during 2 months

Benefit obtained in terms of the reduction in neuroleptic dose

Secondary Outcomes

  • Durability of treatment effect(1, 2 and 3 months)

Study Sites (7)

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