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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04616287
Acronym
SELF-MCL
Enrollment
61
Registered
2020-11-04
Start date
2021-01-25
Completion date
2023-10-23
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERNeuropsychological assessment and Multimodal brain MRI

Neuropsychological assessment and Multimodal brain MRI

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Neuropsychological assessmentmonths 3
Multimodal brain MRImonths 3

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026