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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02492529
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 21, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group [ Time Frame: 3 months ]
  2. Significant effect of the familiarity vs novelty condition on the pattern of % BOLD signal change in across the brain in the AD-MCI group [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Significant group effect on the pattern of % BOLD signal change in across the brain [ Time Frame: 3 months ]
  2. Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI) [ Time Frame: 3 months ]
  3. 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) [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492529


Locations
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France
Centre Hospitalier Universitaire
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02492529    
Other Study ID Numbers: 2014-A01123-44
35RC14_9777_EPMR-MA ( Other Identifier: Rennes University Hospital )
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by Rennes University Hospital:
Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders