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

Primary Purpose

Dementia With Lewy Bodies, Alzheimer Disease, Self

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological assessment and Multimodal brain MRI
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dementia With Lewy Bodies

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

dementia with Lewy bodies

Alzheimer disease

healthy elderly subjects

Arm Description

Outcomes

Primary Outcome Measures

Neuropsychological assessment
Multimodal brain MRI

Secondary Outcome Measures

Full Information

First Posted
November 2, 2020
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT04616287
Brief Title
Self and Autobiographical Memory in Dementia With Lewy Bodies and Alzheimer Disease: a Behavioral and Multimodal Neuroimaging Study
Acronym
SELF-MCL
Official Title
Self in Dementia With Lewy Bodies: a Behavioral and Multimodal Neuroimaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Lewy Bodies, Alzheimer Disease, Self, Autobiographical Memory, Insular Cortex

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dementia with Lewy bodies
Arm Type
Experimental
Arm Title
Alzheimer disease
Arm Type
Active Comparator
Arm Title
healthy elderly subjects
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Neuropsychological assessment and Multimodal brain MRI
Intervention Description
Neuropsychological assessment and Multimodal brain MRI
Primary Outcome Measure Information:
Title
Neuropsychological assessment
Time Frame
months 3
Title
Multimodal brain MRI
Time Frame
months 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie PHILIPPI, MD
Phone
03 88 12 86 31
Ext
0033
Email
nathalie.philippi@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie PHILIPPI, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie PHILIPPI, MD
Phone
03 88 12 86 31
Ext
0033
Email
nathalie.philippi@chru-strasbourg.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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