Clinical trial NCT02020356: Music Therapy in Alzheimer's Disease
Official title: Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer's Type Dementia
Keywords: Alzheimer's disease
Neuroleptics
Music therapy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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©.

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

Primary outcomes:
measure: Neuroleptic reduction dose
timeFrame: during 2 months
Secondary outcomes:
measure: Durability of treatment effect
timeFrame: 1, 2 and 3 months
Other outcomes:
measure: Music therapy session's effects
timeFrame: 4 weeks after completion of music therapy sessions
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
state: Midi-Pyrenees
city: Castres
country: France
facility: EHPAD La Villegiale
state: Tarn
city: Castres
country: France
facility: Residence Christian Bressole
state: Tarn
city: Labruguiere
country: France
facility: EHPAD L'Oustal d'en Thibaud
state: Tarn
city: Lautrec
country: France
facility: EHPAD Les Quietudes
state: Tarn
city: L'Union
country: France
facility: EHPAD KORIAN Grand Maison
city: Toulouse
country: France
facility: Centre Hospitalier Gérard Marchant
Study officials:
affiliation: CHU Toulouse
name: Christophe ARBUS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/gps.1316.
citation: Aldridge D. Music and Alzheimer's disease--assessment and therapy: discussion paper. J R Soc Med. 1993 Feb;86(2):93-5. No abstract available.
citation: 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.
citation: Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.