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

NCT06794580 | Completed

• 1 other identifier: C17-77
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anosognosia

Outcome Measures

Primary Outcomes (1)

• ELECTROPHYSIOLOGICAL AND ELECTRODERMAL MEASURES

  Primary studied parameters include the measure of: i) A classic marker of brain responses to one's own errors, which can be measured by EEG (the so-called error-related negativity, ERN), regarding the individual variability and between-group differences in self-monitoring accuracy; ii) The ERN amplitude and latency, as indexes of self-monitoring ability, regarding subjects' emotional arousal, as studied by the amplitude of electrodermal responses (EDRs); iii) The ERN amplitude and latency, and the EDR amplitudes, regarding the level of anosognosia within the patients' groups.

  45 Minutes

Secondary Outcomes (1)

• NEUROIMAGING

  45 minutes

Study Arms (3)

Controls

One group of 40 cognitively healthy controls (MMSE score, \>27; CDR score, 0; education-, gender-, and aged-matched) that will be recruited among patients' spouses and from the community.

Frontotemporal Dementia

One group of 30 patients fulfilling the core diagnostic features of bvFTD;

ALZHEIMER DISEASE

One group of 30 patients fulfilling the core diagnostic features of AD.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We plan to recruit a total of 100 subjects, including 30 patients with bvFTD, 30 patients with AD, and 40 healthy, age-, gender-, and education level-matched controls. Since the project aims at investigating the mechanistic cascade that makes bvFTD and AD patients to become unaware of their deficits, the testing of such patients and healthy controls is necessary.

You may qualify if:

• 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 :
• 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.

You may not qualify if:

• 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 nervous system; typically, beta-blockers are used to control heart rhythm, treat angina, and reduce high blood pressure.
• Person deprived of their liberty by judicial or administrative decision
• Inability to understand information about the protocol

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Institut de la Mémoire et de la Maladie d'Alzheimer (IM2A)

Paris, Paris, 75013, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 27, 2025
• Study Start: January 22, 2019
• Primary Completion: November 21, 2021
• Study Completion: November 24, 2021
• Last Updated: February 27, 2026

Record last verified: 2025-01

Locations

FR (1)