NCT02833870

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

July 8, 2016

Last Update Submit

December 30, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall score in the Neuropsychiatric Inventory

    up to 11 weeks

Study Arms (3)

Musical intervention

EXPERIMENTAL
Behavioral: Musical intervention

Non-musical (cooking) intervention

EXPERIMENTAL
Behavioral: Non-musical (cooking) intervention

Control with no intervention

ACTIVE COMPARATOR
Behavioral: Control with no intervention

Interventions

Musical intervention
Non-musical (cooking) intervention
Control with no intervention

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

CookingMethods

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Food HandlingFood IndustryIndustryTechnology, Industry, and AgricultureInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 14, 2016

Study Start

September 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 2, 2017

Record last verified: 2016-12

Locations