Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04597827
Other study ID # 38RC20.282
Secondary ID 2020-A02236-33
Status Completed
Phase
First received
Last updated
Start date October 16, 2020
Est. completion date April 27, 2022

Study information

Verified date August 2023
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 abilities.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 27, 2022
Est. primary completion date April 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
Metacognition tests
Test on episodic or semantic memory

Locations

Country Name City State
France CHU Angers Angers
France CHU Bordeaux Bordeaux
France Hôpital Neurologique de Lyon Bron
France Hôpitaux Civils Colmar Colmar
France Chu Grenoble Alpes Grenoble
France CHU Rennes Rennes
Switzerland CHU Vaudois Lausanne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). End of study : around May 2022
Primary 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. End of study : around May 2022
Primary 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). End of study : around May 2022
Primary 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. End of study : around May 2022
Primary 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). End of study : around May 2022
Primary 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). End of study : around May 2022
Primary 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). End of study : around May 2022
Primary 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. End of study : around May 2022
Primary 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). End of study : around May 2022
Primary 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. End of study : around May 2022
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1