Alzheimer DiseasePriMusNCT03342326
Lexical Priming by Music in Alzheimer's Disease and Healthy Aging
A study testing Exposure to familiar songs, Music Experience Questionnaire and Implicit tasks memory in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Exposure to familiar songs, Music Experience Questionnaire and Implicit tasks memory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2018to 29 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of diagnostic criteria for Alzheimer's disease
- Age ≥ 65 years
- MMSE (Mini-mental state Examination) ≥ 20
- 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.
Who cannot join
- Unstable clinical presentation or language presentation in the foreground
- Cognitive disorder of etiology different from that of Alzheimer's disease
- Visual or auditory disorders insufficiently corrected
- Oral or written expression in French insufficient to carry out tests
- Consumption of psychotropic drugs not stabilized
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Exposure to familiar songs, Music Experience Questionnaire, Implicit tasks memory, Questionnaires
- Keywords
- Lexical priming, Healthy Aging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to familiar songsOther
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.
Music Experience QuestionnaireOther
questions about the past music training
Implicit tasks memoryOther
2 tests : a) Completion of trigrams : freely complete the first 3 letters of a word.
- lexical decision : judge whether an audibly presented sound sequence is a word existing in the French language or not.
QuestionnairesOther
Mini Mental State Examination, 5 words by Dubois and fluence verbal test
| Study group | Role | What they receive |
|---|---|---|
| patient with Alzheimer's Disease | Other | 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. Receives: Other: Exposure to familiar songs; Other: Music Experience Questionnaire; Other: Implicit tasks memory |
| healthy volunteer | Other | 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 Receives: Other: Exposure to familiar songs; Other: Music Experience Questionnaire; Other: Implicit tasks memory; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
Reaction time difference for processing words associated with songs presented by their melody alone versus new words (not presented in the exhibition phase).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start3 Apr 2018
- Primary completion29 May 2019
- Study completion29 May 2019
Why it stopped: failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342326
- Sponsor's protocol ID
- 1708117
- Other IDs
- 2017-A02686-47
- Acronym
- PriMus
- Status last verified
- Sep 2020
- First submitted
- 10 Nov 2017
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lexical Priming by Music in Alzheimer's Disease and Healthy Aging
- ClinicalTrials.gov ID
- NCT03342326
- Acronym / sponsor ID
- PriMus / 1708117
- Conditions
- Alzheimer Disease
- Keywords
- Lexical priming, Healthy Aging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure to recruit
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with Alzheimer's Disease | Other | Other: Exposure to familiar songs, Other: Music Experience Questionnaire, Other: Implicit tasks memory1. 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. |
| healthy volunteer | Other | Other: Exposure to familiar songs, Other: Music Experience Questionnaire, Other: Implicit tasks memory, Other: Questionnaires1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of diagnostic criteria for Alzheimer's disease
- Age ≥ 65 years
- MMSE (Mini-mental state Examination) ≥ 20
- Age ≥ 18 years
- Absence of neurological or psychiatric antecedents
Key exclusion criteria (5 listed)
- Unstable clinical presentation or language presentation in the foreground
- Cognitive disorder of etiology different from that of Alzheimer's disease
- Visual or auditory disorders insufficiently corrected
- Oral or written expression in French insufficient to carry out tests
- Consumption of psychotropic drugs not stabilized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to familiar songs3 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 | healthy volunteer, patient with Alzheimer's Disease |
| Music Experience Questionnairequestions about the past music training | Other | healthy volunteer, patient with Alzheimer's Disease |
| Implicit tasks memory2 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, patient with Alzheimer's Disease |
| QuestionnairesMini Mental State Examination, 5 words by Dubois and fluence verbal test | Other | healthy volunteer |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to familiar songs, Music Experience Questionnaire and Implicit tasks memory in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: failure to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.