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

May 22, 2023 updated by: Rennes University Hospital
Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
Other: Experimental procedure
Device: A cranial MRI
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
Other: Experimental procedure
Device: A cranial MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

July 3, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01123-44
  • 35RC14_9777_EPMR-MA (Other Identifier: Rennes University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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