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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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