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

NCT ID: NCT04616287

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2023-10-23

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

dementia with Lewy bodies

Group Type: EXPERIMENTAL

Neuropsychological assessment and Multimodal brain MRI

Intervention Type: OTHER

Neuropsychological assessment and Multimodal brain MRI

Alzheimer disease

Group Type: ACTIVE_COMPARATOR

Neuropsychological assessment and Multimodal brain MRI

Intervention Type: OTHER

Neuropsychological assessment and Multimodal brain MRI

healthy elderly subjects

Group Type: SHAM_COMPARATOR

Neuropsychological assessment and Multimodal brain MRI

Intervention Type: OTHER

Neuropsychological assessment and Multimodal brain MRI

Interventions

Neuropsychological assessment and Multimodal brain MRI

Neuropsychological assessment and Multimodal brain MRI

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie PHILIPPI, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 37106799 (View on PubMed)

Other Identifiers

7942

Identifier Type: -

Identifier Source: org_study_id