Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease (EPMR-MA)

Rennes University Hospital

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Device: A cranial MRI; Other: Neuropsychological tests; Other: Experimental procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02492529

2014-A01123-44

35RC14_9777_EPMR-MA (Other Identifier)

Details and patient eligibility

About

Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Healthy volunteers

Other group

Description:

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

Treatment:

Other: Neuropsychological tests

Other: Experimental procedure

Patients with early Alzheimer disease

Experimental group

Description:

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

Treatment:

Other: Neuropsychological tests

Other: Experimental procedure

Device: A cranial MRI

Old healthy volunteers

Experimental group

Description:

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

Treatment:

Other: Neuropsychological tests

Other: Experimental procedure

Device: A cranial MRI