Music Therapy in Alzheimer's Disease

Not Applicable

Terminated

• Conditions: Alzheimer's Type Dementia

• Registration Number: NCT02020356
• Lead Sponsor: University Hospital, Toulouse

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©.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-24
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neuroleptic reduction dose	during 2 months	Benefit obtained in terms of the reduction in neuroleptic dose

Secondary Outcome Measures

Name	Time	Method
Durability of treatment effect	1, 2 and 3 months	Score on the Cohen-Mansfield scale, Overall NPI score, Quality of life in Alzheimer's disease scale (QOL-AD)

Trial Locations

Locations (7)

University Hospital Toulouse; 🇫🇷 Toulouse, Midi-Pyrenees, France

EHPAD La Villegiale; 🇫🇷 Castres, Tarn, France

Residence Christian Bressole; 🇫🇷 Castres, Tarn, France

EHPAD L'Oustal d'en Thibaud; 🇫🇷 Labruguiere, Tarn, France

EHPAD Les Quietudes; 🇫🇷 Lautrec, Tarn, France

EHPAD KORIAN Grand Maison; 🇫🇷 L'Union, France

Centre Hospitalier Gérard Marchant; 🇫🇷 Toulouse, France