NCT06688968

Brief Summary

The goal of this Multicenter observational pilot study is to Compare the specifics of musical engagement (behaviors related to music in everyday life) in subjects aged over 60 with Alzheimer s disease, Parkinson s disease and control subjects. The main questions it aims to answer are:

  • A semi-structured interview to check the participants eligibility and gather demographic data.
  • Neuropsychological tests and questionnaires will then be administered.
  • A relative of the study participant will help complete questionnaires.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 4, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

November 12, 2024

Last Update Submit

March 14, 2025

Conditions

Keywords

Non Pharmacological interventionAlzheimer Disease, Early OnsetParkinsons Disease with DementiaMusic Therapy

Outcome Measures

Primary Outcomes (1)

  • Comparison of the specificities of musical engagement (i.e., music-related behaviors in daily life) in Alzheimer's disease, Parkinson's disease, and among a population of healthy old adults.

    Global score of informant version of the Music engagement Questionnaire (MusEQ-24) a 24 items questionnaire that delivers an overall score (ranging from 0 to 120) as well as a score for each of its 6 dimensions (ranging from 0 to 5) of musical engagement: Emotion, Daily life, Social, Response, Preferences and Identity. The higher the score, the greater the level of musical engagement.

    Baseline

Secondary Outcomes (26)

  • The comparison of self- and hetero-questionnaires will be carried out within each group for each MUseQ24 dimension

    Baseline

  • Comparison of global cognition between Alzheimer's, Parkinson's and healthy elderly groups

    Baseline

  • Comparison of Executive Function between Alzheimer's, Parkinson's and healthy elderly groups

    Baseline

  • Comparison of Episodic Memory Function between Alzheimer's, Parkinson's and healthy elderly groups

    Baseline

  • Comparison of Semantic Memory Function between Alzheimer's, Parkinson's and healthy elderly groups

    Baseline

  • +21 more secondary outcomes

Study Arms (3)

patient with early-onset Alzheimer's disease (AD)

EXPERIMENTAL

patients followed up at the Centre Mémoire de Ressources et de Recherche (CMRR) of Montpellier, over 60 with Alzheimer's disease who have cognitive impairment based on an MMSE (Mini Mental State Examination) ≥ 20 and live at home with a relative

Behavioral: neuropsychologist interviewBehavioral: questionnaire

patients with parkinson's disease (PD)

ACTIVE COMPARATOR

patients followed up at the Center Expert Parkinson of Montpellier (CEPMo), over 60 with Parkinson's disease who have cognitive impairment based on an MMSE (Mini Mental State Examination) ≥ 20 and live at home with a relative

Behavioral: neuropsychologist interviewBehavioral: questionnaire

Healthy control

ACTIVE COMPARATOR

Subjects aged over 60, with no known neurodegenerative disease, living at home with a relative in the Hérault département.

Behavioral: neuropsychologist interviewBehavioral: questionnaire

Interventions

It will take place either at the hospital or at the participant's home. This interview will consist of : * socio-demographic data collection * neuropsychological tests: * MMSE test (Mini Mental State Examination) cognitive function * RL-RI-16 test (16-item free recall/indexed recall test) * BECS test (Semantic knowledge assessment battery ) * WCST test (Wisconsin Card Sorting Test ) * Musical Cognition Test * Help from the participant's relative to answer certain questions, in particular the MuseEQ-24 questionnaire

Healthy controlpatient with early-onset Alzheimer's disease (AD)patients with parkinson's disease (PD)
questionnaireBEHAVIORAL

The participant answers questionnaires: * Questionnaire MusEQ-24 self reported (Music Engagement Questionnaire) * Questionnaire BMRQ (Barcelona Reward Music Questionnaire) * Questionnaire SHAPS (Snaith-Hamilton Pleasure Scale) * Questionnaire LARS (Lille's Apathy Rating Scale) * Questionnaire PHQ-9 (Patient Health Questionnaire 9 items)

Healthy controlpatient with early-onset Alzheimer's disease (AD)patients with parkinson's disease (PD)

Eligibility Criteria

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

You may qualify if:

  • years and older
  • French-speaking and volunteering for the study
  • Living at home with a relative
  • Biological diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA criteria (McKhann et al., 1984)
  • MMSE greater than or equal to 20
  • Diagnosis of Idiopathic Parkinson's disease
  • MMSE greater than or equal to 20

You may not qualify if:

  • No known neurological pathologies (epilepsy and other non-degenerative CNS diseases) or psychiatric disorders (chronic psychosis and psychotic episodes)
  • Autistic disorders
  • History of stroke or head trauma
  • Unstable medical condition (cancer)
  • Subject unable to read and/or write
  • Hearing impairment without hearing aids
  • Refusal of consent after information
  • Persons unable to give consent, research carried out in emergency situations, etc.)
  • Non-affiliation with a social security scheme
  • Person deprived of liberty (by judicial or administrative decision, or forced hospitalization)
  • Person under legal protection (guardianship, curatorship, legal protection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Montpellier Seniors' Association

Montpellier, Hérault, 34000, France

NOT YET RECRUITING

CHU de Montpellier - CEPMo

Montpellier, Hérault, 34295, France

RECRUITING

CHU de Montpellier - CMRR

Montpellier, Hérault, 34295, France

NOT YET RECRUITING

Related Publications (9)

  • Bian X, Wang Y, Zhao X, Zhang Z, Ding C. Does music therapy affect the global cognitive function of patients with dementia? A meta-analysis. NeuroRehabilitation. 2021;48(4):553-562. doi: 10.3233/NRE-210018.

    PMID: 33967069BACKGROUND
  • Zhang Y, Cai J, An L, Hui F, Ren T, Ma H, Zhao Q. Does music therapy enhance behavioral and cognitive function in elderly dementia patients? A systematic review and meta-analysis. Ageing Res Rev. 2017 May;35:1-11. doi: 10.1016/j.arr.2016.12.003. Epub 2016 Dec 23.

    PMID: 28025173BACKGROUND
  • van der Steen JT, van Soest-Poortvliet MC, van der Wouden JC, Bruinsma MS, Scholten RJ, Vink AC. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2017 May 2;5(5):CD003477. doi: 10.1002/14651858.CD003477.pub3.

    PMID: 28462986BACKGROUND
  • Platel H, Eustache ML, Coppalle R, Viard A, Eustache F, Groussard M, Desgranges B. Boosting Autobiographical Memory and the Sense of Identity of Alzheimer Patients Through Repeated Reminiscence Workshops? Front Psychol. 2021 Feb 15;12:636028. doi: 10.3389/fpsyg.2021.636028. eCollection 2021.

    PMID: 33679562BACKGROUND
  • Morris IB, Vasudevan E, Schedel M, Weymouth D, Loomis J, Pinkhasov T, Muratori LM. Music to One's Ears: Familiarity and Music Engagement in People With Parkinson's Disease. Front Neurosci. 2019 Jun 25;13:661. doi: 10.3389/fnins.2019.00661. eCollection 2019.

    PMID: 31293379BACKGROUND
  • Machado Sotomayor MJ, Arufe-Giraldez V, Ruiz-Rico G, Navarro-Paton R. Music Therapy and Parkinson's Disease: A Systematic Review from 2015-2020. Int J Environ Res Public Health. 2021 Nov 4;18(21):11618. doi: 10.3390/ijerph182111618.

    PMID: 34770129BACKGROUND
  • Loas G, Duru C, Godefroy O, Krystkowiak P. Hedonic deficits in Parkinson's disease: is consummatory anhedonia specific? Front Neurol. 2014 Mar 10;5:24. doi: 10.3389/fneur.2014.00024. eCollection 2014.

    PMID: 24653714BACKGROUND
  • Groussard M, Chan TG, Coppalle R, Platel H. Preservation of Musical Memory Throughout the Progression of Alzheimer's Disease? Toward a Reconciliation of Theoretical, Clinical, and Neuroimaging Evidence. J Alzheimers Dis. 2019;68(3):857-883. doi: 10.3233/JAD-180474.

    PMID: 30883343BACKGROUND
  • Belfi AM, Moreno GL, Gugliano M, Neill C. Musical reward across the lifespan. Aging Ment Health. 2022 May;26(5):932-939. doi: 10.1080/13607863.2021.1871881. Epub 2021 Jan 14.

    PMID: 33442987BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • KARIM BENNYS, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Multicenter observational pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

February 4, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations