Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease
Not Applicable
Completed
- Conditions
- Alzheimer's Disease
- Interventions
- Other: Neuropsychological testsDevice: A cranial MRIOther: Experimental procedure
- Registration Number
- NCT02492529
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.
- Detailed Description
Prospective functional Magnetic Resonance Imaging study involving a group of participants with Mild Cognitive Impairment due to AD and a control participants group matched for age, education level, verbal Intelligence Quotient as assessed through the French version of the National Adult Reading Test and income group following National Institute of Statistics and Economics Studies classification.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Volunteers (pilot phase)
- Aged 25 - 75
- French native speakers
- Right-handed
- Education level equal or superior to primary school leaving certificate
- Free from any medical or psychiatric condition that may impact cognition
- Having given written informed consent
Volunteers (experimental phase)
- Aged 60 - 75
- French native speakers
- Right-handed
- Education level equal or superior to primary school leaving certificate
- Free from any medical or psychiatric condition that may impact cognition
- Having given written informed consent
AD-MCI participants
- Aged 60 - 75
- French native speakers
- Right-handed
- Education level equal or superior to primary school leaving certificate
- Fulfilling criteria for " AD-MCI " (Albert et al., 2011)
- Have been seen in a memory medical center or in Memory Resources and Research Medical Center for cognitive symptoms
- Free from any medical or psychiatric condition that may impact cognition
- Able to understand and consent
- Having given written informed consent
Exclusion Criteria
MRI contraindications (all participants)
-
Claustrophobia
-
Wearing of any metal implant such as:
- Heart pacemaker
- Iron-magnetic surgical clips
- Any metallic foreign body in the eye or brain
Other criteria (all participants)
- Significant history of neurological or psychiatric disorders
- Ongoing medication that may affect cognitive performances
- Sensory deficit that may interfere with the experimental design (e.g. uncorrected visual impairment)
- Lack of sufficient cooperation during the cognitive tasks
- Persons under major legal protection and/or deprived of liberty
Other criteria (control participants)
- Global cognitive impairment attested by Mattis Dementia Rating Scale or Mini-Mental State Examination, according to available normative data
Other criteria (AD-MCI participants)
- 7 items modified Hachinski ischemic score > 2 (Hachinski et al., 2012)
- Dementia (McKahn, et al., 2011)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Old healthy volunteers A cranial MRI 20 healthy volunteers (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure * A cranial MRI Patients with early Alzheimer disease A cranial MRI 20 patients (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure * A cranial MRI Healthy volunteers Experimental procedure 60 old healthy volunteers (aged 25-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure Patients with early Alzheimer disease Neuropsychological tests 20 patients (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure * A cranial MRI Old healthy volunteers Experimental procedure 20 healthy volunteers (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure * A cranial MRI Healthy volunteers Neuropsychological tests 60 old healthy volunteers (aged 25-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure Patients with early Alzheimer disease Experimental procedure 20 patients (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure * A cranial MRI Old healthy volunteers Neuropsychological tests 20 healthy volunteers (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure * A cranial MRI
- Primary Outcome Measures
Name Time Method Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group 3 months Significant effect of the familiarity vs novelty condition on the pattern of % BOLD signal change in across the brain in the AD-MCI group 3 months
- Secondary Outcome Measures
Name Time Method Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI) 3 months Significant group effect on the pattern of % BOLD signal change in across the brain 3 months Significant interaction between the kind of familiarity condition (i.e. novel, experimental or pre-experimental) and the estimates of recognition memory processes efficiency (i.e. respective contributions of recollection and familiarity, % correct) 3 months
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire
🇫🇷Rennes, France