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
About this trial
This is an interventional other trial for Dementia With Lewy Bodies
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
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
NCT ID
NCT04616287
First Posted
November 2, 2020
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
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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