- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04846764
Rapid Declarative Neocortical Declarative Learning in Aging and Memory Diseases (ANéRAVIMM) (ANéRAVIMM)
Rapid Declarative Neocortical Declarative Learning in Aging and Memory
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre-Yves Jonin
- Phone Number: 02 99 28 25 76
- Email: Pierreyves.JONIN@chu-rennes.fr
Study Locations
-
-
-
Rennes, France, 35033
- Recruiting
- CHU Rennes
-
Contact:
- Pierre-Yves JONIN
- Email: Pierreyves.JONIN@chu-rennes.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
Visit 2 • Neuropsychological tests |
Scales and tests to evaluate:
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
Visit 2 • Neuropsychological tests |
Scales and tests to evaluate:
Experimental procedure |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference between young and old healthy subjects in experimental associative memory scores
Time Frame: Up to 1 month (time to perform the second visit)
|
Up to 1 month (time to perform the second visit)
|
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)
|
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
Time Frame: Up to 1 month (time to perform the second visit)
|
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
Time Frame: Up to 1 month (time to perform the second visit)
|
Up to 1 month (time to perform the second visit)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Up to 1 month (time to perform the second visit)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC20_9796_ANéRAVIMM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Neurological Diseases
-
University of LeedsThe Royal College of Surgeons of EnglandCompletedSurgery | Surgery--Complications | Outcome, Fatal | Neurological Disorder | Morality | Neurological Morbidity | Neurological Complication | Comorbidities and Coexisting Conditions | Neurological Diseases or Conditions | Neurological Procedural Complication
-
Hospices Civils de LyonActive, not recruitingNeurological Diseases or Conditions | Neurological Diseases Associated to Anti GFAP AntibodiesFrance
-
Centre Hospitalier Universitaire de la RéunionRecruitingNeurological ComplicationRéunion
-
RWTH Aachen UniversityCompletedNeurological OutcomeGermany
-
BDH-Klinik Hessisch OldendorfRecruitingNeurological RehabilitationGermany
-
The University of Texas Health Science Center,...Recruiting
-
Lady Davis InstituteKripalu Institute and the Mind and Life InstituteCompleted
-
ElMindA LtdCompletedNeurological ObservationsUnited States
-
Ankara UniversityCompletedNeurological ComplicationTurkey
-
Madonna Rehabilitation HospitalActive, not recruitingNeurological Injury | Neurological Diseases or ConditionsUnited States
Clinical Trials on Neuropsychological tests
-
University Hospital, GrenobleUnknownAttention Deficit-HyperactivityFrance
-
Istituto Auxologico ItalianoRecruiting
-
Hospices Civils de LyonCompleted
-
Association pour le Développement et l'Organisation...Association Française du Syndrome d'Ondine; Fonds de Recherche en Santé RespiratoireCompletedHealthy | Amyotrophic Lateral Sclerosis | Ondine SyndromeFrance
-
South Tees Hospitals NHS Foundation TrustUnknown
-
University Medical Center GroningenNot yet recruitingCognitive Dysfunction | Glioma, Malignant
-
University Hospital, Clermont-FerrandRecruiting
-
University Hospital, BordeauxCompletedAttention-Deficit/Hyperactivity DisorderFrance
-
University Hospital, CaenUnknown
-
Mid and South Essex NHS Foundation TrustAnglia Ruskin UniversityCompleted