Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020356
Recruitment Status : Terminated
First Posted : December 24, 2013
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE May 30, 2013
First Posted Date  ICMJE December 24, 2013
Last Update Posted Date February 6, 2018
Study Start Date  ICMJE April 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
Neuroleptic reduction dose [ Time Frame: during 2 months ]
Benefit obtained in terms of the reduction in neuroleptic dose
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
Neuroloeptic reduction dose [ Time Frame: during 2 months ]
Benefit obtained in terms of the reduction in neuroleptic dose
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 18, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Music Therapy in Alzheimer's Disease
Official Title  ICMJE Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.
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©.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Alzheimer's Type Dementia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Music therapy
  • 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.
    Intervention: Behavioral: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 2, 2015)
35
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2013)
40
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 100 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02020356
Other Study ID Numbers  ICMJE RC31/12/0385
AOL 2012 ( Other Grant/Funding Number: Local funding )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christophe ARBUS, MD CHU Toulouse
PRS Account University Hospital, Toulouse
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP