Memory DisordersNEMNCT06564779
Development, Standardisation and Standardisation Project for a New Memory Assessment
An observational study of Memory Disorders, run by University Hospital, Tours at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Memory Disorders
- What is being tested?
- New memory assessment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2024to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient attending a memory consultation for suspected Alzheimer's disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University hospital
Tours, 37044
Alix LAUNAY, 0247470458 ext. +33, a.launay@chu-tours.fr
About this study
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.
- Conditions
- Memory Disorders
- Being tested
- New memory assessment
- Keywords
- Alzheimer, Episodic memory
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New memory assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group intervention | patients benefiting from the new memory assessment Receives: Other: New memory assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score total NEM (new memory assessment)
Sum of the episodic elements
Measured: baseline
Secondary outcomes (3)
NEM sub-scores
Sum of the episodic elements by category
Measured: baseline
Total RL/RI 16 Recall
(Van der Linden et al., 2014)
Measured: baseline
Delayed Mem Logic Recall
(MEM IV, Wechsler, 2014)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start22 Nov 2024
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alix LAUNAY, Principal investigator, Tours University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564779
- Sponsor's protocol ID
- DR240067-NEM
- Acronym
- NEM
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Standardisation and Standardisation Project for a New Memory Assessment
- ClinicalTrials.gov ID
- NCT06564779
- Acronym / sponsor ID
- NEM / DR240067-NEM
- Conditions
- Memory Disorders
- Keywords
- Alzheimer, Episodic memory
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 21 Aug 2024 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group intervention | – | Other: New memory assessmentpatients benefiting from the new memory assessment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient attending a memory consultation for suspected Alzheimer's disease.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| New memory assessmentThe 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. | Other | group intervention |
Primary outcome
Score total NEM (new memory assessment)
Time frame: baseline
Sum of the episodic elements
3 secondary outcomes
NEM sub-scores
Time frame: baseline
Total RL/RI 16 Recall
Time frame: baseline
Delayed Mem Logic Recall
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Alix LAUNAY principal investigator
Tours University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Memory Disorders, run by University Hospital, Tours 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alix LAUNAY (0247470458 ext. +33, a.launay@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score total NEM (new memory assessment) (time frame: baseline). 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 30 Apr 2026.