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

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02492529

Collaborator

(none)

100

Enrollment

Location

Arms

29.4

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Other: Neuropsychological tests Device: A cranial MRI Other: Experimental procedure	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 21, 2015

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy volunteers 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 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 Other: Experimental procedure
Experimental: Patients with early Alzheimer disease 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 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 Device: A cranial MRI Other: Experimental procedure
Experimental: Old healthy volunteers 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 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 Device: A cranial MRI Other: Experimental procedure

Arm

Intervention/Treatment

Other: Healthy volunteers

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

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

Other: Experimental procedure

Experimental: Patients with early Alzheimer disease

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

Device: A cranial MRI

Other: Experimental procedure

Experimental: Old healthy volunteers

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

Device: A cranial MRI

Other: Experimental procedure

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire	Rennes		France	35033

Sponsors and Collaborators

Rennes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT02492529

Other Study ID Numbers:

2014-A01123-44
35RC14_9777_EPMR-MA

First Posted:

Jul 8, 2015

Last Update Posted:

Jan 23, 2018

Last Verified:

Jan 1, 2018

Keywords provided by Rennes University Hospital

Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Jan 23, 2018