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

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04616287
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 34.2
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia With Lewy Bodies; Alzheimer Disease; Self; Autobiographical Memory; Insular Cortex	Other: Neuropsychological assessment and Multimodal brain MRI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Self in Dementia With Lewy Bodies: a Behavioral and Multimodal Neuroimaging Study
• Actual Study Start Date: Jan 25, 2021
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dementia with Lewy bodies	Other: Neuropsychological assessment and Multimodal brain MRI; Neuropsychological assessment and Multimodal brain MRI
Active Comparator: Alzheimer disease	Other: Neuropsychological assessment and Multimodal brain MRI; Neuropsychological assessment and Multimodal brain MRI
Sham Comparator: healthy elderly subjects	Other: Neuropsychological assessment and Multimodal brain MRI; Neuropsychological assessment and Multimodal brain MRI

Outcome Measures

Primary Outcome Measures

1. Neuropsychological assessment [months 3]

2. Multimodal brain MRI [months 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67000

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Principal Investigator: Nathalie PHILIPPI, MD, Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT04616287
• Other Study ID Numbers: 7942
• First Posted: Nov 4, 2020
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease; Dementia; Lewy Body Disease

Study Results

No Results Posted as of Jul 8, 2022