Non-pharmacological Care of Alzheimer's Disease: Benefice of Musical Interventions (MusicAlzheimer)

Non-drug Taken Charge of Alzheimer's Disease: Profit Musical Activities

Cares of Alzheimer's disease (AD) and related disorders are presenting a real public health challenge. Because of the limited effectiveness of pharmacological treatments, there is a growing interest in care approach based on nonpharmacological treatments, such as musical interventions. Several lines of evidence suggest that musical interventions could improve behaviour, emotion and even cognition in patients with AD. However, very few studies respond to the methodological constraints required for clinical controlled trials carried out in well selected groups of patients. The efficiency of such care approaches is not scientifically proved yet and the impact of musical interventions has rarely been compared to another pleasant intervention, leaving open the question about the specific benefits of music in patients with dementia. The main goal of this research project is to demonstrate short and longer-term efficiencies and the specificity of musical interventions in dementia by investigating their effects not only in patients but also in familial and professional caregivers.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease (AD) and Related Disorders
• Intervention / Treatment: Behavioral: Musical intervention; Behavioral: Non-musical (cooking) intervention; Behavioral: Control with no intervention

Detailed Description

To generalize previous results showing that non pharmacological therapy based on musical interventions improved emotional state in patients with severe AD to a larger sample of patients and to demonstrate the possible effects on caregivers, the investigators carried out a randomized controlled study with three parallel arms in institutionalized patients with severe AD (study 1) and in patients with mild AD leaving at home (study 2) to compare the impact of two interventions, a musical and a non-musical (cooking), to a control group (without any intervention). The control activity (cooking) was selected because it shares different features with music. Both interventions provide pleasure, are multisensory and may trigger old memories. In addition, both activities can be carried out in groups. A protocol consisting of various selected tests and questionnaires was used to assess the emotional, behavioural and cognitive abilities. Professional and familial caregivers also filled out other questionnaires to assess potential indirect benefits from both interventions on caregiver burnout and familial caregiver burden. Six assessments were proposed, two before, two during and two after interventions (follow-up) to respectively evaluate short and longer-term benefits of both interventions whereas test -retest effects will be controlled. Psychologists in charge to these assessments will be blind in regard to patients' group (musical versus cooking sessions, no intervention). Data were analyzed with methods from social psychology to decode non-verbal behaviours (e.g. visual contact) and emotional indexes in facial and verbal expressions and with methods from classical neuropsychology and from health domain. The collaboration between the two university teams from Lille and the special care unit (Pole EHPAD-USLD in Reims Hospital) provided complementary skills to this project that ensured its feasibility.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • CHU de Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Older People and francophones living in institutions
• Presenting a cortical degenerative disease
• Male or female
• Age 60 to 99 years
• French Mother tongue
• People enjoying a social security scheme
• Patient Participation Agreement and of the person of trust or his legal representative.

Exclusion Criteria:

• Patients without cortical degenerative disease
• Patients with uncorrected profound hearing loss
• Not affiliated with a social security scheme Patients .
• Patients refusing to participate in the study or with the agreement of the person of trust or his legal representative was not obtained
• Patient protected by law

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Musical intervention	Behavioral: Musical intervention
Experimental: Non-musical (cooking) intervention	Behavioral: Non-musical (cooking) intervention
Active Comparator: Control with no intervention	Behavioral: Control with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall score in the Neuropsychiatric Inventory	up to 11 weeks

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Estimate): January 2, 2017
• Last Update Submitted That Met QC Criteria: December 30, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: PO13125 252Au12