- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342326
Lexical Priming by Music in Alzheimer's Disease and Healthy Aging (PriMus)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Saint-Étienne, France, 42055
- CHU de Saint Etienne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
|
Other: patient with Alzheimer's Disease
|
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.
questions about the past music training
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
|
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.
questions about the past music training
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.
Mini Mental State Examination, 5 words by Dubois and fluence verbal test
|
What is the study measuring?
Primary Outcome Measures
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
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Secondary Outcome Measures
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1708117
- 2017-A02686-47 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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