Music Therapy in Alzheimer's Disease
PRE-MUSICAL
Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.
2 other identifiers
interventional
35
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 30, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFebruary 6, 2018
February 1, 2018
2.2 years
May 30, 2013
February 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neuroleptic reduction dose
Benefit obtained in terms of the reduction in neuroleptic dose
during 2 months
Secondary Outcomes (1)
Durability of treatment effect
1, 2 and 3 months
Other Outcomes (1)
Music therapy session's effects
4 weeks after completion of music therapy sessions
Study Arms (2)
Music therapy
EXPERIMENTAL"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
PLACEBO COMPARATORInterview 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.
Interventions
"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.
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- Decompensated physical disease
- Inability to give informed consent
- Lack of health insurance coverage
- Non-corrected hearing impairment
- treatment ongoing with two or more neuroleptics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University Hospital Toulouse
Toulouse, Midi-Pyrenees, 31059, France
EHPAD La Villegiale
Castres, Tarn, 81100, France
Residence Christian Bressole
Castres, Tarn, 81100, France
EHPAD L'Oustal d'en Thibaud
Labruguière, Tarn, 81290, France
EHPAD Les Quietudes
Lautrec, Tarn, 81440, France
EHPAD KORIAN Grand Maison
L'Union, France
Centre Hospitalier Gérard Marchant
Toulouse, France
Related Publications (5)
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.
PMID: 15920712BACKGROUNDAldridge D. Music and Alzheimer's disease--assessment and therapy: discussion paper. J R Soc Med. 1993 Feb;86(2):93-5. No abstract available.
PMID: 8433315BACKGROUNDBenoit 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.
PMID: 15791352BACKGROUNDCohen-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.
PMID: 2715584BACKGROUNDvan der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.
PMID: 40049590DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe ARBUS, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2013
First Posted
December 24, 2013
Study Start
April 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
February 6, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share