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

Primary Purpose

Alzheimer's Type Dementia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Music therapy
Placebo
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer's Type Dementia focused on measuring Alzheimer's disease, Neuroleptics, Music therapy

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Toulouse
  • EHPAD La Villegiale
  • Residence Christian Bressole
  • EHPAD L'Oustal d'en Thibaud
  • EHPAD Les Quietudes
  • EHPAD KORIAN Grand Maison
  • Centre Hospitalier Gérard Marchant

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Music therapy

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Neuroleptic reduction dose
Benefit obtained in terms of the reduction in neuroleptic dose

Secondary Outcome Measures

Durability of treatment effect
Score on the Cohen-Mansfield scale, Overall NPI score, Quality of life in Alzheimer's disease scale (QOL-AD)

Full Information

First Posted
May 30, 2013
Last Updated
February 2, 2018
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02020356
Brief Title
Music Therapy in Alzheimer's Disease
Acronym
PRE-MUSICAL
Official Title
Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. 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.
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©.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Type Dementia
Keywords
Alzheimer's disease, Neuroleptics, Music therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music therapy
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Music therapy
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention 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.
Primary Outcome Measure Information:
Title
Neuroleptic reduction dose
Description
Benefit obtained in terms of the reduction in neuroleptic dose
Time Frame
during 2 months
Secondary Outcome Measure Information:
Title
Durability of treatment effect
Description
Score on the Cohen-Mansfield scale, Overall NPI score, Quality of life in Alzheimer's disease scale (QOL-AD)
Time Frame
1, 2 and 3 months
Other Pre-specified Outcome Measures:
Title
Music therapy session's effects
Description
Proportions of patients in the two groups who discontinued neuroleptics, Scores on the Cohen-Mansfield scale, Dose of neuroleptics
Time Frame
4 weeks after completion of music therapy sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe ARBUS, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
State/Province
Midi-Pyrenees
ZIP/Postal Code
31059
Country
France
Facility Name
EHPAD La Villegiale
City
Castres
State/Province
Tarn
ZIP/Postal Code
81100
Country
France
Facility Name
Residence Christian Bressole
City
Castres
State/Province
Tarn
ZIP/Postal Code
81100
Country
France
Facility Name
EHPAD L'Oustal d'en Thibaud
City
Labruguiere
State/Province
Tarn
ZIP/Postal Code
81290
Country
France
Facility Name
EHPAD Les Quietudes
City
Lautrec
State/Province
Tarn
ZIP/Postal Code
81440
Country
France
Facility Name
EHPAD KORIAN Grand Maison
City
L'Union
Country
France
Facility Name
Centre Hospitalier Gérard Marchant
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15920712
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.
Results Reference
background
PubMed Identifier
8433315
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.
Results Reference
background
PubMed Identifier
15791352
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.
Results Reference
background
PubMed Identifier
2715584
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.
Results Reference
background

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Music Therapy in Alzheimer's Disease

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