Lexical Priming by Music in Alzheimer's Disease and Healthy Aging (PriMus)

September 9, 2020 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators study the stimulation by the song, material integrating language and music, and having an autobiographical value. The investigators measure the lexical priming capacity of the song, that is, its ability to activate and maintain lexical and semantic representations, which are threatened with alteration in the course of the disease.

This lexical priming effect by song is measured in patients with mild Alzheimer's disease and healthy volunteers during a single test session. In the first phase of the session, participants are exposed to familiar songs, presented in sung, spoken or instrumental form, whose popularity they evaluate. In the second phase, they perform two implicit memory tasks: a trigram completion task and a lexical decision task. These tests measure the facilitation of the processing of words evoked by songs in relation to words unrelated to songs, reflecting a "long-term" memory update of mnemic traces of primed words.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France, 42055
        • CHU de Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for patients :

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

Exclusion Criteria for patient :

  • Unstable clinical presentation or language presentation in the foreground
  • Cognitive disorder of etiology different from that of Alzheimer's disease

Inclusion Criteria for volunteers :

  • 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.

Exclusion Criteria for volunteers :

  • Visual or auditory disorders insufficiently corrected
  • Oral or written expression in French insufficient to carry out tests
  • Consumption of psychotropic drugs not stabilized

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: patient with Alzheimer's Disease
  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 songs
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.
Other: Music Experience Questionnaire
questions about the past music training
Other: Implicit tasks memory

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.
Other: healthy volunteer
  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 songs
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.
Other: Music Experience Questionnaire
questions about the past music training
Other: Implicit tasks memory

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.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Reaction time difference for processing words associated with songs presented by their melody alone versus new words (not presented in the exhibition phase).
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1708117
  • 2017-A02686-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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