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

• ClinicalTrials.gov Identifier: NCT02020356
• Recruitment Status: Terminated
• First Posted: December 24, 2013
• Last Update Posted: February 6, 2018
• Sponsor: University Hospital, Toulouse
• Information provided by (Responsible Party): University Hospital, Toulouse

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Type Dementia	Behavioral: Music therapy; Behavioral: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.
• Study Start Date: April 2013
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Music therapy; "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.	Behavioral: Music therapy; "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.
Placebo Comparator: Placebo; 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.	Behavioral: Placebo; 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.

Outcome Measures

Primary Outcome Measures :

1. Neuroleptic reduction dose [ Time Frame: during 2 months ]
   Benefit obtained in terms of the reduction in neuroleptic dose

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Music therapy session's effects [ Time Frame: 4 weeks after completion of music therapy sessions ]
   Proportions of patients in the two groups who discontinued neuroleptics, Scores on the Cohen-Mansfield scale, Dose of neuroleptics

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 100 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

University Hospital Toulouse

Toulouse, Midi-Pyrenees, France, 31059

EHPAD La Villegiale

Castres, Tarn, France, 81100

Residence Christian Bressole

Castres, Tarn, France, 81100

EHPAD L'Oustal d'en Thibaud

Labruguiere, Tarn, France, 81290

EHPAD Les Quietudes

Lautrec, Tarn, France, 81440

EHPAD KORIAN Grand Maison

L'Union, France

Centre Hospitalier Gérard Marchant

Toulouse, France

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

• Principal Investigator: Christophe ARBUS, MD; CHU Toulouse

More Information

Publications:

Aalten P, de Vugt ME, Jaspers N, Jolles J, Verhey FR. The course of neuropsychiatric symptoms in dementia. Part I: findings from the two-year longitudinal Maasbed study. Int J Geriatr Psychiatry. 2005 Jun;20(6):523-30.

Aldridge D. Music and Alzheimer's disease--assessment and therapy: discussion paper. J R Soc Med. 1993 Feb;86(2):93-5.

Benoit M, Robert PH, Staccini P, Brocker P, Guerin O, Lechowski L, Vellas B; REAL.FR Group. One-year longitudinal evaluation of neuropsychiatric symptoms in Alzheimer's disease. The REAL.FR Study. J Nutr Health Aging. 2005;9(2):95-9.

Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT02020356
• Other Study ID Numbers: RC31/12/0385; AOL 2012 ( Other Grant/Funding Number: Local funding )
• First Posted: December 24, 2013
• Last Update Posted: February 6, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:

Alzheimer's disease; Neuroleptics; Music therapy

Additional relevant MeSH terms:

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