NCT04327778

Brief Summary

Alzheimer disease is the most common neurodegenerative brain disease that causes cognitive impairment in the elderly but also behavioral and psychological symptoms. Among these symptoms, agitation is one of the most dangerous because it put the patient and their caregivers in danger. Sleep disorders can be the cause of many psychiatric symptoms leading directly or indirectly to agitation. Music therapy is the non-drug therapy which has been shown to be the most effective in managing agitation and sleep disorders. With the MAGE protocol, the investigators propose to take care of behavioral disorders in severe Alzheimer patients living in nursing home through sequences of music therapy (stimulation, relaxation) automatically initiated by an actigraph that will detect sleep disorders. These subjects will be exposed for 2 weeks over a month. Behavioral and sleep disorders will be evaluated objectively by actigraphy but also by standardized scales, as the others neuropsychiatric symptoms found classically in this disease. Thanks to this project, the investigators hope to improve the quality of life of these patients by preventing them from putting themselves in danger, by reducing their neuropsychiatric symptoms and their use of medication, which has often deleterious side effect and also by reducing the workload of caregivers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

March 27, 2020

Last Update Submit

April 6, 2020

Conditions

Alzheimer DiseaseMajor Neurocognitive Disorder

Outcome Measures

Primary Outcomes (2)

  • Neuropsychiatric tests scores

    NeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120

    At 3 months

  • Nightly agitation

    The number of movements of the patient by the actigraphy, before exposure and at the end of each exposure

    At 3 month

Secondary Outcomes (3)

  • Number of falls

    At 3 months

  • Sleeping troubles

    At 3 months

  • Rate of anxiety

    At 3 months

Study Arms (1)

Music therapy

EXPERIMENTAL

Patients will be exposed every two weeks

Procedure: Music Therapy

Interventions

Music TherapyPROCEDURE

Automate music therapy every two weeks

Music therapy

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 60 years old
  • Male or Female
  • Patients with a diagnosis of Alzheimer disease according to the criteria of NINCDS-ADRDA or typical or atypical Alzheimer disease
  • MMSE \< 20
  • Patient residing in nursing home
  • Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator)
  • Affiliation to a social security system

You may not qualify if:

  • Prescription of a new psychotropic treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in week prior to the evaluation
  • Hearing loss preventing the patient from responding perfectly to the therapeutic solutions provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Hakima LABSI, Project manager

CONTACT

0033492034504labsi.h@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 31, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2020

Study Completion

August 1, 2021

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

FR(1)