ADAE: Validation of a Remediation Method for Memory Disorders Using Motor and Emotional Encoding in Patients With Alzheimer's Disease

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06105047
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Memories are more robust when they are multitraced. This means that the more a piece of information is mediated by different sensory inputs, the more resistant it is to being forgotten. Many works in the field of embodied cognition show that new learnings are better recalled over the long term when they are learned during body mobilization. Other works show that musical stimulation could be a good way of eliciting physiological and emotional states more favorable to the memorization of new contents. However, to date, no studies have examined the positive effects of these two tools combined in Alzheimer's disease. The investigators suggest that it is possible to optimize memory in Alzheimer's disease by referring to their motor and emotional resources. The hypothesis is that information will be better recalled with multimodal enriched learning.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Behavioral: Cognitive tests	N/A

Detailed Description

In a within subjects design, all patients take part in four conditions. In each condition, sentences describing actions will be displayed. 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; and 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. The main criterion used in our statistical analyses will be the discrimination threshold.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Validation of a Remediation Method for Memory Disorders Using Motor and Emotional Encoding in Patients With Alzheimer's Disease (AD)
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Patients with Alzheimer disease Patients will perform experimental task in four conditions : control, mime, emotion, dual

Behavioral: Cognitive tests; . 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 quiz : Geneva Music Induced Checklist, GMIAC, Coutinho & Scherer, 2017

Outcome Measures

Primary Outcome Measures

1. Comparison of the recognition score obtained in each of the experimental conditions to the recognition score obtained in the control condition [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

Secondary Outcome Measures

1. Geneva Music-Induced Affect Checklist results [Weeks: 2]

   Analysis Geneva Music-Induced Affect Checklist results. It is composed of 4 sub-score dimensions such as valence, activation, tension (stress level) and pleasure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Saint-Etienne	Saint-Étienne		France	42055

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Céline BORG, MD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT06105047
• Other Study ID Numbers: 23CH154; ANSM
• First Posted: Oct 27, 2023
• Last Update Posted: Oct 27, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Alzheimer; Action memory; Musical memory
• Additional relevant MeSH terms: Alzheimer Disease; Memory Disorders

Study Results

No Results Posted as of Oct 27, 2023