Music Therapy in Alzheimer's Disease

N/ATerminatedNCT02020356

University Hospital, Toulouse35 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Alzheimer's Type Dementia

Interventions

Music therapyBEHAVIORAL

"U" sequence: the musical sequence lasts 20 minutes and is made up of several phases that progressively induce a relaxed state in the patient. The phase of maximum relaxation is followed by a stimulating phase.

PlaceboBEHAVIORAL

Interview with an occupational activity (such as discussion of personal pictures or news) with the caregiver in charge of music therapy sessions with the same period.

Eligibility

Sex: ALLMin age: 65 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

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

Labruguière, Tarn, France

Outcomes

Primary Outcomes

Neuroleptic reduction dose

Benefit obtained in terms of the reduction in neuroleptic dose

Time frame: during 2 months

Secondary Outcomes

Durability of treatment effect

Score on the Cohen-Mansfield scale, Overall NPI score, Quality of life in Alzheimer's disease scale (QOL-AD)

Time frame: 1, 2 and 3 months

Data from ClinicalTrials.gov

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