Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease

Study Overview
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Brief Summary
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Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.

Detailed Description
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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.

Official Title
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Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Other: Neuropsychological tests
* Device: A cranial MRI
* Other: Experimental procedure


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteers<br>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 | Other: Neuropsychological tests<br>* Scales and tests to evaluate: Global cognitive performance Handedness Memory functions performance Gestural praxis functions performance Lexical and semantic functions performance Executive functions performance Memory disorders Way of life Mood<br>Other: Experimental procedure<br> <br> |
| Experimental: Patients with early Alzheimer disease<br>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 | Other: Neuropsychological tests<br>* Scales and tests to evaluate: Global cognitive performance Handedness Memory functions performance Gestural praxis functions performance Lexical and semantic functions performance Executive functions performance Memory disorders Way of life Mood<br>Device: A cranial MRI<br> <br> Other: Experimental procedure<br> <br> |
| Experimental: Old healthy volunteers<br>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 | Other: Neuropsychological tests<br>* Scales and tests to evaluate: Global cognitive performance Handedness Memory functions performance Gestural praxis functions performance Lexical and semantic functions performance Executive functions performance Memory disorders Way of life Mood<br>Device: A cranial MRI<br> <br> Other: Experimental procedure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant group effect on the pattern of % BOLD signal change in across the brain |  | 3 months | 
| Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI