Music Therapy in Alzheimer's Disease (PRE-MUSICAL)

Toulouse University Hospital

Status: Terminated

Conditions: Alzheimer's Type Dementia

Treatments: Behavioral: Music therapy; Behavioral: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02020356

RC31/12/0385

AOL 2012 (Other Identifier)

Details and patient eligibility

About

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.

Full 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©.

Enrollment: 35 patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups, including a placebo group

Music therapy

Experimental group

Description:

"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.

Treatment:

Behavioral: Music therapy

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Placebo