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

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ClinicalTrials.gov Identifier: NCT03342326
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: Exposure to familiar songs Other: Music Experience Questionnaire Other: Implicit tasks memory Other: Questionnaires Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Lexical Priming by Music in Alzheimer's Disease and Healthy Aging
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.


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




Primary Outcome Measures :
  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. [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342326


Contacts
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Contact: Isabelle ROUCH, MD (0)4 77 12 78 05 ext 33 isabelle.rouch@chu-st-etienne.fr
Contact: Marie PEURIERE (0)4 77 82 92 72 ext 33 marie.peuriere@chu-st-etienne.fr

Locations
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France
CHU de Saint Etienne Recruiting
Saint-Étienne, France, 42055
Contact: Isabelle ROUCH, MD    (0)4 77 12 78 05 ext 33    isabelle.rouch@chu-st-etienne.fr   
Sub-Investigator: Bernard LAURENT, MD PhD         
Sub-Investigator: Jean Claude GETENET, MD         
Sub-Investigator: Nicolas AUGUSTE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03342326     History of Changes
Other Study ID Numbers: 1708117
2017-A02686-47 ( Other Identifier: ANSM )
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Lexical priming
Healthy Aging

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders