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Rapid Declarative Neocortical Declarative Learning in Aging and Memory Diseases (ANéRAVIMM) (ANéRAVIMM)

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ClinicalTrials.gov Identifier: NCT04846764
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neurological Diseases Central Nervous System Other: Neuropsychological tests Not Applicable

Detailed Description:

Three experimental cognitive tasks will be used in the ANéRAVIMM study. The first two tasks have been selected based on the literature and previous work of CHU Rennes team. They are two experiments that have produced promising results concerning the existence of a rapid neocortical learning system in declarative memory, and have in common the use of prior knowledge to promote learning.

In the first part of the study, these two tasks will be put in competition for their resistance to the effects of age. Brain aging is characterized by its deleterious impact on hippocampal functioning, and memory aging leads to an alteration of associative memory. Therefore, this first part will allow the learning paradigm that presents the best potential in brain-damaged patients to be retained in the second part of the ANéRAVIMM study.

The third task stems from recent work by CHU Rennes team in collaboration with Dr. Besson of the University of Liege, in the context of a very recent model of memory. It aims at estimating the ability to develop a representation of visual objects in memory at the entity level, i.e. an integrated representation, unifying all the perceptual, conceptual and contextual features of perceived information. This task has been adapted for the ANéRAVIMM project in order to test the hypothesis that this mnemonic representational level of the entity in memory could support rapid neocortical associative learning in declarative memory.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Rapid Declarative Neocortical Declarative Learning in Aging and Memory
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : October 28, 2022
Estimated Study Completion Date : October 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Healthy volunteers

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

Scales and tests to evaluate:

  • laterality
  • anxiety
  • depression
  • professional level
  • education level
  • pre-morbid level
  • memory disorders

Experimental procedure
Experimental: Patients with neurological diseases of the central nervous system

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

Scales and tests to evaluate:

  • laterality
  • anxiety
  • depression
  • professional level
  • education level
  • pre-morbid level
  • memory disorders

Experimental procedure


Outcome Measures
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Primary Outcome Measures :
  1. Difference between young and old healthy subjects in experimental associative memory scores [ Time Frame: Up to 1 month (time to perform the second visit) ]
  2. Difference between healthy subjects and patients with SSHA damage in experimental associative memory scores [ Time Frame: Up to 1 month (time to perform the second visit) ]
  3. Correlations between SSHA volumes and experimental associative memory scores in healthy subjects and patients with SSHA damage [ Time Frame: Up to 1 month (time to perform the second visit) ]
  4. Correlations between rest-related functional connectivity within the Medial Temporal Lobes and experimental associative memory scores in healthy subjects [ Time Frame: Up to 1 month (time to perform the second visit) ]

Secondary Outcome Measures :
  1. Presence of significant correlations between memory scores for entity-level mnemonic representations and experimental associative memory scores in healthy subjects [ Time Frame: Up to 1 month (time to perform the second visit) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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
  • 1 KA patient, suffering from the rare syndrome of developmental amnesia

Exclusion Criteria:

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

  • 7-items modified Hachinski ischemic score >2
  • dementia
  • epileptic seizure in the month prior to inclusion for epileptic patients undergoing surgery and limbic encephalitis patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846764


Contacts
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Contact: Pierre-Yves Jonin 02 99 28 25 76 Pierreyves.JONIN@chu-rennes.fr

Locations
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France
CHU Rennes Recruiting
Rennes, France, 35033
Contact: Pierre-Yves JONIN       Pierreyves.JONIN@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04846764    
Other Study ID Numbers: 35RC20_9796_ANéRAVIMM
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nervous System Diseases