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OpenTrials
Completed

NCT Number: NCT04616287

Self and Autobiographical Memory in Dementia With Lewy Bodies and Alzheimer Disease: 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuropsychological assessment and Multimodal brain MRI

Other

Neuropsychological assessment and Multimodal brain MRI

Primary outcomes

  1. Neuropsychological assessment

    Time frame: months 3

  2. Multimodal brain MRI

    Time frame: months 3

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: SELF-MCL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2020
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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