CompletedNot Applicable

THE DUAL-SYSTEM HYPOTHESIS OF ANOSOGNOSIA: The Interplay Between Emotional Processing and Self-Monitoring in Neurodegenerative Patients

France77 participantsStarted 2019-01-22

Plain-language summary

The ASSESS project is a monocenter, regionally based, study evaluating the pathophysiological/functional processes underlying anosognosia in both AD and bvFTD. The multimodal analysis will be applied to the obtained cognitive, neuroimaging and electrophysiological data in order to describe the mechanistic cascade of anosognosia and their neuronal and electrophysiological biomarkers. Importantly, it has the potential to significantly impact society by: i) addressing a fundamental scientific question towards a causal understanding on how self-awareness emerges in the human brain; and ii) developing a cognitive BCI-system, which will allow us to validated neurophenomenologically EEG biomarkers in anosognosia, and may give us access in later steps to neurofeedback applications for the improvement of self-awareness in early stages of AD and bvFTD, with major social and economic gains.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: PATIENTS and HEALTHY CONTROLS : * French speakers\*, age ≥ 50 ≤ 85 years of age, with normal color vision or corrected-tonormal visual acuity, * Capacity to consent, * Covered by social security, * Ability to undergo MRI scanning, * The spouse / caregiver is able to accompany the subject to both visits and ready to complete questionnaires. * Already in menopause (for women) PATIENTS : 30 patients fulfilling the core diagnostic features of bvFTD; 30 patients fulfilling the core diagnostic features of AD; both in a mild to moderate cognitive and functional severity stage, as determined by: MMSE score greater than or equal to 18, and CDR global score less than or equal to 2, Grober et Buschke: TRGB \< 42 as well as clinical signs (subjective impression) of anosognosia. HEALTHY SUBJECTS (n=40) : MMSE score ≥ 27;TRGB\> 42 Education, gender-, and aged-matched controls. \* Subjects will be administered neuropsychological tests that have been validated for French speakers. Exclusion Criteria: * Illiteracy /unable to count or to read; * Having a neurological disorder, such as: epilepsy, extrapyramidal signs, brain tumour, subdural haematoma, history of head trauma followed by persistent neurological deficits (motor, sensory or cognitive); stroke that has occurred in the last three months; * Report of a present or prior major psychiatric disorder; * Potentially confounding medications, particularly beta-blockers that may have effects on the peripheral nervou…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ELECTROPHYSIOLOGICAL AND ELECTRODERMAL MEASURES

Timeframe: 45 Minutes

Trial details

NCT IDNCT06794580

SponsorInstitut National de la Santé Et de la Recherche Médicale, France

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2021-11-21

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