Self and Autobiographical Memory in Dementia With Lewy Bodies and Alzheimer Disease: a Behavioral and Multimodal Neuroimaging Study (SELF-MCL)

Self in Dementia With Lewy Bodies: a Behavioral and Multimodal Neuroimaging Study

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Dementia With Lewy Bodies; Autobiographical Memory; Self; Insular Cortex
• Intervention / Treatment: Other: Neuropsychological assessment and Multimodal brain MRI

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Inclusion criteria for all participants:

• Male or female aged between 60 to 80, at the inclusion visit
• 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

Inclusion criteria for group of dementia with Lewy bodies:

• 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
• Availability of a caregiver for the inclusion visit

Inclusion criteria for group of Alzheimer disease:

• Subject meeting Dubois et al. criteria (2014)
• Subject with prodromal or mild Alzheimer disease with an ≤ 20 MMSE score
• Availability of a caregiver for the inclusion visit

Inclusion criteria for healthy elderly:

• Subject must be matched with patients in terms of age, gender and educational level
• Absence of any cognitive complaint
• Autonomy must be preserved

Exclusion Criteria:

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
• Subject in period of exclusion (determined by a previous or ongoing study)
• Inability to give the subject informed information
• Subject under judicial protection
• Subject under tutorship or guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dementia with Lewy bodies	Other: Neuropsychological assessment and Multimodal brain MRI; Neuropsychological assessment and Multimodal brain MRI
Active Comparator: Alzheimer disease	Other: Neuropsychological assessment and Multimodal brain MRI; Neuropsychological assessment and Multimodal brain MRI
Sham Comparator: healthy elderly subjects	Other: Neuropsychological assessment and Multimodal brain MRI; Neuropsychological assessment and Multimodal brain MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neuropsychological assessment	months 3
Multimodal brain MRI	months 3

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Nathalie PHILIPPI, MD, Hôpitaux Universitaires de Strasbourg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): October 23, 2023

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Alzheimer Disease; Lewy Body Disease; Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests
• Other Study ID Numbers: 7942

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No