- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06564779
Development, Standardisation and Standardisation Project for a New Memory Assessment (NEM)
April 29, 2026 updated by: University Hospital, Tours
Episodic memory (EM) is a neuropsychological marker of Alzheimer's disease (AD) (Thomas-Anterion, 2006).
Current tests for its assessment do not take into account the identity and emotional aspects of memory (Van der Linden et al., 2018).
However, there are models that integrate links with identity, self-awareness and experience.
Pause et al. (2013) propose criteria to create ecological tools, including consideration of the emotional valence of memories and the spatio-temporal context of acquisition.
In line with these criteria, we have developed a new tool: the NEM (New evaluation of Episodic Memory).
Preliminary studies show different response profiles on the NEM among patients (Launay et al., 2023).
We now want to evaluate the relevance of this tool in the differential diagnosis of AD.
Study Overview
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alix LAUNAY
- Phone Number: +33 0247470458
- Email: a.launay@chu-tours.fr
Study Locations
-
-
-
Tours, France, 37044
- Recruiting
- University Hospital
-
Contact:
- Alix LAUNAY
- Phone Number: +33 0247470458
- Email: a.launay@chu-tours.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patient attending a memory consultation for suspected Alzheimer's disease.
Description
Inclusion Criteria:
- Age ≥ 50 years
- Ability to understand judged sufficient by the assessor;
- Amnesic MCI profile (Petersen, 2003) during the 1st medical consultation prior to the assessment being prescribed.
Exclusion Criteria:
- Severe auditory and/or visual sensory impairment not compatible with neuropsychological assessment;
- Judged fit to take the test by the assessor;
- Patient under guardianship, curatorship or family guardianship;
- Opposition to data processing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group intervention
patients benefiting from the new memory assessment
|
The intervention is part of the neuropsychological assessment carried out as part of routine care.
It consists of carrying out the neuropsychological tests traditionally used to investigate the diagnostic hypothesis of Alzheimer's disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score total NEM (new memory assessment)
Time Frame: baseline
|
Sum of the episodic elements
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NEM sub-scores
Time Frame: baseline
|
Sum of the episodic elements by category
|
baseline
|
|
Total RL/RI 16 Recall
Time Frame: baseline
|
(Van der Linden et al., 2014)
|
baseline
|
|
Delayed Mem Logic Recall
Time Frame: baseline
|
(MEM IV, Wechsler, 2014)
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alix LAUNAY, Tours University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2024
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Study Registration Dates
First Submitted
August 19, 2024
First Submitted That Met QC Criteria
August 19, 2024
First Posted (Actual)
August 21, 2024
Study Record Updates
Last Update Posted (Actual)
April 30, 2026
Last Update Submitted That Met QC Criteria
April 29, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DR240067-NEM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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