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

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



Sponsors


Source

Centre Hospitalier Universitaire de Saint Etienne

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

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.

Overall Status

Not yet recruiting

Start Date

2018-02-01

Completion Date

2020-02-01

Primary Completion Date

2020-02-01

Phase

N/A

Study Type

Interventional

Primary 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.
Day 1

Secondary 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).
Day 1

Enrollment

78

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

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.

Arm Group Label

patient with Alzheimer's Disease

healthy volunteer



Intervention Type

Other

Intervention Name


Description

questions about the past music training

Arm Group Label

patient with Alzheimer's Disease

healthy volunteer



Intervention Type

Other

Intervention Name


Description

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.

Arm Group Label

patient with Alzheimer's Disease

healthy volunteer



Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

healthy volunteer



Eligibility

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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Overall Contact

Last Name

Isabelle ROUCH, MD

Phone

(0)4 77 12 78 05

Phone Ext

33

Email



Location

Facility

Status

Contact

Investigator

CHU de Saint Etienne
Saint-Étienne 42055 France
Not yet recruiting
Last Name: Isabelle ROUCH, MD
Phone: (0)4 77 12 78 05
Phone Ext: 33
Email: [email protected]
Last Name: Bernard LAURENT, MD PhD
Role: Sub-Investigator

Last Name: Jean Claude GETENET, MD
Role: Sub-Investigator

Last Name: Nicolas AUGUSTE, MD
Role: Sub-Investigator


Location Countries

Country

France


Verification Date

2017-11-01

Lastchanged Date

2017-11-10

Firstreceived Date

2017-11-10

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Secondary Id

2017-A02686-47

Number Of Arms

2

Arm Group

Arm Group Label

patient with Alzheimer's Disease

Arm Group Type

Other

Description

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.


Arm Group Label

healthy volunteer

Arm Group Type

Other

Description

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



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Marie PEURIERE

Phone

(0)4 77 82 92 72

Phone Ext

33

Email



Acronym

PriMus

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Other

Masking

None (Open Label)


Study First Submitted

November 10, 2017

Study First Submitted Qc

November 10, 2017

Study First Posted

November 14, 2017

Last Update Submitted

November 10, 2017

Last Update Submitted Qc

November 10, 2017

Last Update Posted

November 17, 2017


ClinicalTrials.gov processed this data on November 17, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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