NCT06564779

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started Nov 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Nov 2024Nov 2028

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 22, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

August 19, 2024

Last Update Submit

April 29, 2026

Conditions

Keywords

AlzheimerEpisodic memory

Outcome Measures

Primary Outcomes (1)

  • Score total NEM (new memory assessment)

    Sum of the episodic elements

    baseline

Secondary Outcomes (3)

  • NEM sub-scores

    baseline

  • Total RL/RI 16 Recall

    baseline

  • Delayed Mem Logic Recall

    baseline

Study Arms (1)

group intervention

patients benefiting from the new memory assessment

Other: New memory assessment

Interventions

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.

group intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient attending a memory consultation for suspected Alzheimer's disease.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alix LAUNAY

    Tours University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

November 22, 2024

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations