- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06105047
Validation of a Remediation Method for Memory Disorders Using Motor and Emotional Encoding in Patients With Alzheimer's Disease (ADAE)
Validation of a Remediation Method for Memory Disorders Using Motor and Emotional Encoding in Patients With Alzheimer's Disease (AD)
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Céline BORG, MD
- Phone Number: +33 (0)477127805
- Email: celine.borg@univ-st-etienne.fr
Study Locations
-
-
-
Grenoble, France
- Recruiting
- CHU Grenoble
-
Contact:
- Mathilde SAUVEE, Md
-
Principal Investigator:
- Mathilde SAUVEE, Md
-
Sub-Investigator:
- Olivier MOREAUD, Md
-
Saint-Étienne, France, 42055
- Recruiting
- CHU DE SAINT-ETIENNE
-
Principal Investigator:
- Céline BORG, MD
-
Villeurbanne, France
- Recruiting
- HCL
-
Contact:
- Isabelle ROUCH, Md
-
Principal Investigator:
- Isabelle ROUCH, MD
-
Sub-Investigator:
- Céline BORG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Alzheimer's disease by one of the consulting physicians, neurologist and/or geriatrician of whom the patient has been informed.
- Early stage (MMSE ≥ 22)
- Neuropsychological assessment within 6 months of inclusion.
- Affiliation with a social security scheme
- Age equal to or greater than 60
- French mother tongue
- Agreement to participate / signature of consent form
Exclusion Criteria:
- Uncorrected perceptual disorders
- Other neurological or psychiatric history
- Inability to communicate
- Delusional or psychotic state
- Person unable to give informed consent
- Refusal to participate
- Participation in a study on a drug/medical device/care technique likely to affect cognitive functions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with Alzheimer disease
Patients will perform experimental task in four conditions : control, mime, emotion, dual
|
. Patients will perform experimental task in four conditions : control, mime, emotion, dual In a control condition : they will be asked to read the sentence aloud; in a motor-only condition, they will also be asked to mime the sentence; in an emotional-only condition, they will be asked to read the sentence while listening to music; in a dual condition, they will be asked to both mime and listen to music. Immediately after each condition, they will realize a recognition task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Discrimination score"
Time Frame: Weeks: 2
|
Comparison of the recognition score obtained in each of the experimental conditions to the recognition score obtained in the control condition The score = the Number of correct answer (0 to 15, the higher score means better outcome)
|
Weeks: 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Geneva Music-Induced Affect Checklist" scale
Time Frame: Weeks: 2
|
Analysis Geneva Music-Induced Affect Checklist scale results.
It is composed of 4 sub-score dimensions such as valence, activation, tension (stress level) and pleasure (14 items scale 1: "not at all" to 5 "hugely, it's a qualitative scale)
|
Weeks: 2
|
Collaborators and Investigators
Investigators
- Principal Investigator: Céline BORG, MD, CHU Saint-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 23CH154
- ANSM (Other Identifier: 2024-A00286-41)
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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