Music Therapy in Alzheimer's Disease

Alzheimer's Type Dementia Clinical Trial

— PRE-MUSICAL  

Official title:

Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02020356
• Other study ID #: RC31/12/0385
• Secondary ID: AOL 2012
• Status: Terminated
• Phase: N/A
• First received: May 30, 2013
• Last updated: February 2, 2018
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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©.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Type Dementia
• Dementia

Intervention

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
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.

Locations

Country	Name	City	State
France	EHPAD La Villegiale	Castres	Tarn
France	Residence Christian Bressole	Castres	Tarn
France	EHPAD KORIAN Grand Maison	L'Union
France	EHPAD L'Oustal d'en Thibaud	Labruguiere	Tarn
France	EHPAD Les Quietudes	Lautrec	Tarn
France	Centre Hospitalier Gérard Marchant	Toulouse
France	University Hospital Toulouse	Toulouse	Midi-Pyrenees

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Music therapy session's effects	Proportions of patients in the two groups who discontinued neuroleptics, Scores on the Cohen-Mansfield scale, Dose of neuroleptics	4 weeks after completion of music therapy sessions
Primary	Neuroleptic reduction dose	Benefit obtained in terms of the reduction in neuroleptic dose	during 2 months
Secondary	Durability of treatment effect	Score on the Cohen-Mansfield scale, Overall NPI score, Quality of life in Alzheimer's disease scale (QOL-AD)	1, 2 and 3 months