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

• ClinicalTrials.gov Identifier: NCT03342326
• Recruitment Status: Terminated
• First Posted: November 14, 2017
• Last Update Posted: September 11, 2020
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 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
• Actual Primary Completion Date: May 29, 2019
• Actual Study Completion Date: May 29, 2019

Arms and Interventions

Arm	Intervention/treatment
patient with Alzheimer's Disease; 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.; Music Experience Questionnaire : questions about the past music training; 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; 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.; Music Experience Questionnaire : questions about the past music training; 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.; 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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

CHU de Saint Etienne

Saint-Étienne, France, 42055

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

More Information

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT03342326
• Other Study ID Numbers: 1708117; 2017-A02686-47 ( Other Identifier: ANSM )
• First Posted: November 14, 2017
• Last Update Posted: September 11, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders