- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04597827
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
- Name: Olivier MOREAUD
- Phone Number: (33)4.76.76.57.90
- Email: omoreaud@chu-grenoble.fr
Study Contact Backup
- Name: Céline SOUCHAY
- Phone Number: 33 (0)6 72 23 12 97
- Email: celine.souchay@univ-grenoble-alpes.fr
Study Locations
-
-
-
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
-
-
-
-
-
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
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 |
Intervention / Treatment |
---|---|
Semantic dementia
Diagnosis of semantic dementia (revised criteria Moreaud et al., 2008; based on Neary et al., 1998)
|
Test on episodic or semantic memory
|
Alzheimer's disease
NIAAA 2011 criteria
|
Test on episodic or semantic memory
|
Control
MMSE above 27, no neurological or psychiatric disorder
|
Test on episodic or semantic memory
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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)
October 16, 2020
Primary Completion (Actual)
April 27, 2022
Study Completion (Actual)
April 27, 2022
Study Registration Dates
First Submitted
October 1, 2020
First Submitted That Met QC Criteria
October 16, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
August 4, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Tauopathies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Dementia
- Alzheimer Disease
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID 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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