Self and Autobiographical Memory in Dementia With Lewy Bodies and Alzheimer Disease: a Behavioral and Multimodal Neuroimaging Study

NCT04616287 | Completed

• 1 other identifier: 7942
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The present project aims at exploring different components of Self-consciousness or 'the Self', such as autobiographical memory, self-concept and subjective sense of Self, in dementia with Lewy Bodies (DLB) compared to Alzheimer's disease and to normal ageing. Anatomical substrates will be studied in multimodal imaging, in terms of volume, anatomical and functional connectivity. We expect to find an alteration of the different components of the Self, consecutive to insular dysfunction, a key region within cerebral networks of self-consciousness, which is damaged early in the course of the disease.

Conditions

Dementia With Lewy Bodies; Alzheimer Disease; Self; Autobiographical Memory; Insular Cortex

Outcome Measures

Primary Outcomes (2)

• Neuropsychological assessment

  months 3

• Multimodal brain MRI

  months 3

Study Arms (3)

dementia with Lewy bodies

EXPERIMENTAL

Other: Neuropsychological assessment and Multimodal brain MRI

Alzheimer disease

ACTIVE COMPARATOR

Other: Neuropsychological assessment and Multimodal brain MRI

healthy elderly subjects

SHAM COMPARATOR

Other: Neuropsychological assessment and Multimodal brain MRI

Interventions

Neuropsychological assessment and Multimodal brain MRI OTHER

Neuropsychological assessment and Multimodal brain MRI

Alzheimer disease; dementia with Lewy bodies; healthy elderly subjects

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right-handed
• Must be affiliated to a social health insurance protection scheme
• Must be able both to understand the objectives and risks related to the study and to give a dated and signed informed consent
• Fluency in French
• At least 9 years of formal education
• Subject meeting McKeith et al. criteria (2017)
• Subject with prodromal dementia with Lewy bodies meeting the DSM-V Mild Cognitive Impairment criteria (2013)
• Subject with prodromal or mild dementia with Lewy bodies with an ≤ 20 MMSE score
• Subject meeting Dubois et al. criteria (2014)
• Subject with prodromal or mild Alzheimer disease with an ≤ 20 MMSE score
• Subject must be matched with patients in terms of age, gender and educational level
• Absence of any cognitive complaint
• Autonomy must be preserved

You may not qualify if:

• Subjects with significant neuropsychiatric comorbidities
• Abnormal neurological examination
• Sensory impairment that may significantly interfere with testing
• Contraindication to MRI
• Claustrophobia
• Heavy psychotropic drug treatment
• Excessive and regular consumption of alcohol
• Inability to give the subject informed information
• Subject under judicial protection
• Subject under tutorship or guardianship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

Related Publications (1)

• Tisserand A, Philippi N, Botzung A, Blanc F. Me, Myself and My Insula: An Oasis in the Forefront of Self-Consciousness. Biology (Basel). 2023 Apr 14;12(4):599. doi: 10.3390/biology12040599.

  PMID: 37106799 BACKGROUND

MeSH Terms

Conditions

Lewy Body Disease; Alzheimer Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Nathalie PHILIPPI, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 4, 2020
• Study Start: January 25, 2021
• Primary Completion: June 14, 2023
• Study Completion: October 23, 2023
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)