NCT04846764

Brief Summary

Learning a person's name, new words, or simply remembering where the last conversation with a friend was held are examples of associative memory, frequently disturbed in brain pathologies, but also by aging. Although typically dependent on the hippocampus in the brain, a series of findings suggest that associative memory may persist, under certain circumstances, despite hippocampal damage. The ANéRAVIMM project aims to reveal this learning system, its cognitive and cerebral bases, and to evaluate its potential in patients with memory disorders.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 22, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2024

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

3.1 years

First QC Date

December 22, 2020

Last Update Submit

July 27, 2023

Conditions

Neurological DiseasesCentral Nervous System

Outcome Measures

Primary Outcomes (4)

  • Difference between young and old healthy subjects in experimental associative memory scores

    Up to 1 month (time to perform the second visit)

  • Difference between healthy subjects and patients with SSHA damage in experimental associative memory scores

    Up to 1 month (time to perform the second visit)

  • Correlations between SSHA volumes and experimental associative memory scores in healthy subjects and patients with SSHA damage

    Up to 1 month (time to perform the second visit)

  • Correlations between rest-related functional connectivity within the Medial Temporal Lobes and experimental associative memory scores in healthy subjects

    Up to 1 month (time to perform the second visit)

Secondary Outcomes (1)

  • Presence of significant correlations between memory scores for entity-level mnemonic representations and experimental associative memory scores in healthy subjects

    Up to 1 month (time to perform the second visit)

Study Arms (2)

Healthy volunteers

ACTIVE COMPARATOR

60 healthy volunteers (aged 18-40 and 60-80) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: Visit 1 * Neuropsychological tests * A cranial MRI Visit 2 • Neuropsychological tests

Other: Neuropsychological tests

Patients with neurological diseases of the central nervous system

EXPERIMENTAL

36 patients will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: Visit 1 * Neuropsychological tests * A cranial MRI Visit 2 • Neuropsychological tests

Other: Neuropsychological tests

Interventions

Neuropsychological testsOTHER

Scales and tests to evaluate: * laterality * anxiety * depression * professional level * education level * pre-morbid level * memory disorders Experimental procedure

Healthy volunteersPatients with neurological diseases of the central nervous system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Volunteers
  • aged 18 to 40 years old and aged 60 to 80 years old
  • native French speaker
  • right-handed
  • with a level of education greater than or equal to the Certificate of Primary Education
  • free of any medical or psychiatric condition that may interfere with cognition
  • Neurological patients
  • patients with mild neurocognitive impairment due to Alzheimer's disease
  • patients with semantic dementia syndrome
  • right-handed patients with a right or left unilateral surgical lesion of the anterior temporal lobe as a result of pharmaco resistant temporal epilepsy, with no seizures in the last 6 months, with a memory quotient greater than 75, and free of internal extra temporal lesions on MRI
  • patients with autoimmune limbic encephalitis who have been seizure-free for one month
  • KA patient, suffering from the rare syndrome of developmental amnesia

You may not qualify if:

  • All participants
  • MRI contraindications
  • sensory deficit interfering with experimental tests
  • protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
  • Healthy volunteers
  • \- deficit score on the MoCA scale according to current calibrations
  • Neurologic patients
  • items modified Hachinski ischemic score \>2
  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, 35033, France

RECRUITING

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Pierre-Yves Jonin

CONTACT

02 99 28 25 76Pierreyves.JONIN@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

April 15, 2021

Study Start

April 28, 2021

Primary Completion

May 28, 2024

Study Completion

May 28, 2024

Last Updated

July 28, 2023

Record last verified: 2023-07

Locations

FR(1)