Metacognition in Semantic Dementia: Comparison With Alzheimer's Disease (META-DEM)

August 4, 2023 updated by: University Hospital, Grenoble
This study aims at exploring patients' ability to monitor their own memory performance depending on their primary deficit and the type of memory involved in the criterion task. The goal is to evaluate if semantic dementia (SD) and Alzheimer's disease (AD) differently affect patients' awareness of their memory abilities.

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

Patients who will give their informed non-opposition will be included. Participants will undergo 6 metacognitive tasks in which they will be tested on newly learnt information (i.e., episodic memory) or prior knowledge (i.e., semantic memory) and asked to evaluate their performance either prior or after the test. Correlation between their evaluation and their actual performance will be measured. Performance and correlations will be compared across groups.

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.
Observational

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.
40

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49 933
        • CHU Angers
      • Bordeaux, France, 33000
        • CHU Bordeaux
      • Bron, France, 69677
        • Hôpital Neurologique de Lyon
      • Colmar, France, 68024
        • Hôpitaux Civils Colmar
      • Grenoble, France, 38043
        • Chu Grenoble Alpes
      • Rennes, France, 35033
        • CHU Rennes
  • Switzerland
      • Lausanne, Switzerland, 1011
        • CHU vaudois

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with Alzheimer's disease will be patients at the CHU of Grenoble.

Patients with Alzheimer's disease will be recruited in the CHU Grenoble, CHU Angers, CHU Bordeaux, CHU Colmar, CHU Lyon, CHU Rennes and CHUV Lausanne.

Controls will be recruited via the database "Seniors pour la Science ", https://seniorspourlascience.fr/

Description

Inclusion Criteria:

  • native French-speakers
  • normal or corrected-to-normal vision
  • for patients ONLY : doctor-approved diagnosis of semantic dementia or Alzheimer's disease
  • for healthy participants ONLY: score above 27 on the MMSE
  • non-opposition in participation

Exclusion Criteria:

  • other neurological/ psychiatric disorder, or cognitive disorder that might affect general cognition
  • drug or alcohol abuse

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Semantic dementia
Diagnosis of semantic dementia (revised criteria Moreaud et al., 2008; based on Neary et al., 1998)
Other: Metacognition tests
Test on episodic or semantic memory
Alzheimer's disease
NIAAA 2011 criteria
Other: Metacognition tests
Test on episodic or semantic memory
Control
MMSE above 27, no neurological or psychiatric disorder
Other: Metacognition tests
Test on episodic or semantic memory

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
Measure Description
Time Frame
Metacognitive bias on the episodic predictive judgment task
Time Frame: End of study : around May 2022
Metacognitive bias will be assessed by subtracting the mean proportion of the metacognitive judgments to the actual memory performance. Bias will range from -1 (underestimation) to 1 (overestimation).
End of study : around May 2022
Metacognitive accuracy on the episodic predictive judgment task
Time Frame: End of study : around May 2022
Metacognitive accuracy will be assessed by calculating a gamma correlation for each participant. Metacognition accuracy allows to evaluate people's ability to discriminate correct responses from incorrect responses. Gamma correlation range from -1 to 1.
End of study : around May 2022
Metacognitive bias on the semantic predictive judgment task
Time Frame: End of study : around May 2022
Metacognitive bias will be assessed by subtracting the mean proportion of the metacognitive judgments to the actual memory performance. Bias will range from -1 (underestimation) to 1 (overestimation).
End of study : around May 2022
Metacognitive accuracy on the semantic predictive judgment task
Time Frame: End of study : around May 2022
Metacognitive accuracy will be assessed by calculating a gamma correlation for each participant. Metacognition accuracy allows to evaluate people's ability to discriminate correct responses from incorrect responses. Gamma correlation range from -1 to 1.
End of study : around May 2022
Metacognitive bias on episodic global judgment task
Time Frame: End of study : around May 2022
Metacognitive bias will be assessed by subtracting the mean proportion of the metacognitive judgments to the actual memory performance. Bias will range from -1 (underestimation) to 1 (overestimation).
End of study : around May 2022
Metacognitive bias on semantic global judgment task
Time Frame: End of study : around May 2022
Metacognitive bias will be assessed by subtracting the mean proportion of the metacognitive judgments to the actual memory performance. Bias will range from -1 (underestimation) to 1 (overestimation).
End of study : around May 2022
Metacognitive bias on the episodic retrospective judgment task
Time Frame: End of study : around May 2022
Metacognitive bias will be assessed by subtracting the mean proportion of the metacognitive judgments to the actual memory performance. Bias will range from -1 (underestimation) to 1 (overestimation).
End of study : around May 2022
Metacognitive accuracy on the episodic retrospective judgment task
Time Frame: End of study : around May 2022
Metacognitive accuracy will be assessed by calculating a gamma correlation for each participant. Metacognition accuracy allows to evaluate people's ability to discriminate correct responses from incorrect responses. Gamma correlation range from -1 to 1.
End of study : around May 2022
Metacognitive bias on the semantic retrospective judgment task
Time Frame: End of study : around May 2022
Metacognitive bias will be assessed by subtracting the mean proportion of the metacognitive judgments to the actual memory performance. Bias will range from -1 (underestimation) to 1 (overestimation).
End of study : around May 2022
Metacognitive accuracy on the semantic retrospective judgment task
Time Frame: End of study : around May 2022
Metacognitive accuracy will be assessed by calculating a gamma correlation for each participant. Metacognition accuracy allows to evaluate people's ability to discriminate correct responses from incorrect responses. Gamma correlation range from -1 to 1.
End of study : around May 2022

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.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Moreaud, University Hospital, Grenoble

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.
October 16, 2020

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.
April 27, 2022

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.
April 27, 2022

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).
October 1, 2020

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.
October 16, 2020

First Posted (Actual)

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.
October 22, 2020

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.
August 7, 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.
August 4, 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.
August 1, 2023

More Information

Terms related to this study

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.
  • 38RC20.282
  • 2020-A02236-33 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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