NCT03342326

Brief Summary

While verbal memory is quickly reached in the wake of Alzheimer's disease, the musical memory remains preserved until a late stage of the disease. This observation encouraged the development of music-based therapies in the management of neurocognitive and behavioral disorders that characterize Alzheimer's disease. In order to develop rehabilitation programs that effectively target cognitive functions to stimulate, it is necessary to understand the mechanisms underlying this beneficial effect of music on cognition.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

April 3, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

November 10, 2017

Last Update Submit

September 9, 2020

Conditions

Keywords

Lexical primingHealthy Aging

Outcome Measures

Primary Outcomes (1)

  • Reaction time difference for the treatment of words that have been presented in sing condition in the exposure phase versus words presented in spoken condition.

    Day 1

Secondary Outcomes (1)

  • Reaction time difference for processing words associated with songs presented by their melody alone versus new words (not presented in the exhibition phase).

    Day 1

Study Arms (2)

patient with Alzheimer's Disease

OTHER

1. Exposure to familiar songs : a) Words and Music (sing condition), b) Words only (spoken condition) and c) Music only (instrumental condition) After each song : rate the popularity of the song on a scale of 1 to 5. 2. Music Experience Questionnaire : questions about the past music training 3. Implicit tasks memory : a) Completion of trigrams : freely complete the first 3 letters of a word. b) lexical decision : judge whether an audibly presented sound sequence is a word existing in the French language or not.

Other: Exposure to familiar songsOther: Music Experience QuestionnaireOther: Implicit tasks memory

healthy volunteer

OTHER

1. Exposure to familiar songs : a) Words and Music (sing condition), b) Words only (spoken condition) and c) Music only (instrumental condition) After each song : rate the popularity of the song on a scale of 1 to 5. 2. Music Experience Questionnaire : questions about the past music training 3. Implicit tasks memory : a) Completion of trigrams : freely complete the first 3 letters of a word. b) lexical decision : judge whether an audibly presented sound sequence is a word existing in the French language or not. 4. For volunteer over 65 years : Mini Mental State Examination, 5 words by Dubois and fluence verbal test

Other: Exposure to familiar songsOther: Music Experience QuestionnaireOther: Implicit tasks memoryOther: Questionnaires

Interventions

3 conditions : a) Words and Music (sing condition), b) Words only (spoken condition) and c) Music only (instrumental condition) After each song : rate the popularity of the song on a scale of 1 to 5.

healthy volunteerpatient with Alzheimer's Disease

questions about the past music training

healthy volunteerpatient with Alzheimer's Disease

2 tests : a) Completion of trigrams : freely complete the first 3 letters of a word. b) lexical decision : judge whether an audibly presented sound sequence is a word existing in the French language or not.

healthy volunteerpatient with Alzheimer's Disease

Mini Mental State Examination, 5 words by Dubois and fluence verbal test

healthy volunteer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of diagnostic criteria for Alzheimer's disease
  • Age ≥ 65 years
  • MMSE (Mini-mental state Examination) ≥ 20

You may not qualify if:

  • Unstable clinical presentation or language presentation in the foreground
  • Cognitive disorder of etiology different from that of Alzheimer's disease
  • Age ≥ 18 years
  • Absence of neurological or psychiatric antecedents
  • For those aged 65 or over: MMSE (Mini-mental state Examination) greater than or equal to 27; non-pathological performance against the 5 words of Dubois and the verbal fluency test.
  • Visual or auditory disorders insufficiently corrected
  • Oral or written expression in French insufficient to carry out tests
  • Consumption of psychotropic drugs not stabilized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 14, 2017

Study Start

April 3, 2018

Primary Completion

May 29, 2019

Study Completion

May 29, 2019

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations