Semantic DementiaMETA-DEMNCT04597827
Metacognition in Semantic Dementia: Comparison With Alzheimer's Disease
An observational study of Semantic Dementia and Alzheimer Disease, run by University Hospital, Grenoble at 7 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Semantic Dementia, Alzheimer Disease, Healthy
- What is being tested?
- Metacognition tests
- How many people
- 40 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 16 Oct 2020to 27 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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/
Who may be able to join
- 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
Who cannot join
- other neurological/ psychiatric disorder, or cognitive disorder that might affect general cognition
- drug or alcohol abuse
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France6 sites
CHU Angers
Angers, 49 933
CHU Bordeaux
Bordeaux, 33000
Hôpital Neurologique de Lyon
Bron, 69677
Hôpitaux Civils Colmar
Colmar, 68024
Chu Grenoble Alpes
Grenoble, 38043
CHU Rennes
Rennes, 35033
About this study
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.
Read the 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.
- Conditions
- Semantic Dementia, Alzheimer Disease, Healthy
- Being tested
- Metacognition tests
- Medical subject headings
- Frontotemporal Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognition testsOther
Test on episodic or semantic memory
| Study group | Role | What they receive |
|---|---|---|
| Semantic dementia | Diagnosis of semantic dementia (revised criteria Moreaud et al., 2008; based on Neary et al., 1998) Receives: Other: Metacognition tests | |
| Alzheimer's disease | NIAAA 2011 criteria Receives: Other: Metacognition tests | |
| Control | MMSE above 27, no neurological or psychiatric disorder Receives: Other: Metacognition tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metacognitive bias on the episodic predictive judgment task
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).
Measured: End of study : around May 2022
Metacognitive accuracy on the episodic predictive judgment task
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.
Measured: End of study : around May 2022
Metacognitive bias on the semantic predictive judgment task
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).
Measured: End of study : around May 2022
Metacognitive accuracy on the semantic predictive judgment task
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.
Measured: End of study : around May 2022
Metacognitive bias on episodic global judgment task
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).
Measured: End of study : around May 2022
Metacognitive bias on semantic global judgment task
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).
Measured: End of study : around May 2022
Metacognitive bias on the episodic retrospective judgment task
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).
Measured: End of study : around May 2022
Metacognitive accuracy on the episodic retrospective judgment task
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.
Measured: End of study : around May 2022
Metacognitive bias on the semantic retrospective judgment task
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).
Measured: End of study : around May 2022
Metacognitive accuracy on the semantic retrospective judgment task
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.
Measured: End of study : around May 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start16 Oct 2020
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Semantic DementiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier MOREAUD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597827
- Sponsor's protocol ID
- 38RC20.282
- Other IDs
- 2020-A02236-33
- Acronym
- META-DEM
- Status last verified
- Aug 2023
- First submitted
- 1 Oct 2020
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognition in Semantic Dementia: Comparison With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04597827
- Acronym / sponsor ID
- META-DEM / 38RC20.282
- Conditions
- Semantic Dementia, Alzheimer Disease, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semantic dementia | – | Other: Metacognition testsDiagnosis of semantic dementia (revised criteria Moreaud et al., 2008; based on Neary et al., 1998) |
| Alzheimer's disease | – | Other: Metacognition testsNIAAA 2011 criteria |
| Control | – | Other: Metacognition testsMMSE above 27, no neurological or psychiatric disorder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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/
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- other neurological/ psychiatric disorder, or cognitive disorder that might affect general cognition
- drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognition testsTest on episodic or semantic memory | Other | Alzheimer's disease, Control, Semantic dementia |
Primary outcome
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).
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.
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).
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.
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).
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).
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).
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
Related trials for Semantic Dementia
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
PSP - Progressive Supranuclear Palsy
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Not yet recruitingObservational study
Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease
Alzheimer's Disease, Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier MOREAUD principal investigator
University Hospital, Grenoble
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Semantic Dementia and Alzheimer Disease, run by University Hospital, Grenoble at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metacognitive bias on the episodic predictive judgment task (time frame: End of study : around May 2022). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.