Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Oct 2020

Geographic Reach

2 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

October 1, 2020

Completed

15 days until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed

Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

October 1, 2020

Last Update Submit

August 4, 2023

Conditions

Semantic Dementia Alzheimer Disease Healthy

Outcome Measures

Primary Outcomes (10)

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
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
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
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
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
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
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
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
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
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

Study Arms (3)

Semantic dementia

Diagnosis of semantic dementia (revised criteria Moreaud et al., 2008; based on Neary et al., 1998)

Other: Metacognition tests

Alzheimer's disease

NIAAA 2011 criteria

Other: Metacognition tests

Control

MMSE above 27, no neurological or psychiatric disorder

Other: Metacognition tests

Interventions

Metacognition testsOTHER

Test on episodic or semantic memory

Alzheimer's diseaseControlSemantic dementia

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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/

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University Hospital, Grenoblelead

Study Sites (7)

CHU Angers

Angers, 49 933, France

Location

CHU Bordeaux

Bordeaux, 33000, France

Location

Hôpital Neurologique de Lyon

Bron, 69677, France

Location

Hôpitaux Civils Colmar

Colmar, 68024, France

Location

Chu Grenoble Alpes

Grenoble, 38043, France

Location

CHU Rennes

Rennes, 35033, France

Location

CHU Vaudois

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Frontotemporal DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Frontotemporal Lobar DegenerationDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeurocognitive DisordersMental DisordersTauopathies

Study Officials

Olivier MOREAUD
University Hospital, Grenoble
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 22, 2020

Study Start

October 16, 2020

Primary Completion

April 27, 2022

Study Completion

April 27, 2022

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations

CH(1)FR(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (10)

Study Arms (3)

Semantic dementia

Alzheimer's disease

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations