Dementia With Lewy BodiesSELF-MCLNCT04616287
Self and Autobiographical Memory in Dementia With Lewy Bodies and Alzheimer Disease: a Behavioral and Multimodal Neuroimaging Study
A study testing Neuropsychological assessment and Multimodal brain MRI in people with Dementia With Lewy Bodies and Alzheimer Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia With Lewy Bodies, Alzheimer Disease, Self
- What is being tested?
- Neuropsychological assessment and Multimodal brain MRI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to 23 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
- Subject must be matched with patients in terms of age, gender and educational level
- Absence of any cognitive complaint
- Autonomy must be preserved
Who cannot join
- Subjects with significant neuropsychiatric comorbidities
- Abnormal neurological examination
- Sensory impairment that may significantly interfere with testing
- Contraindication to MRI
- Claustrophobia
- Heavy psychotropic drug treatment
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self in Dementia With Lewy Bodies: 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.
- Conditions
- Dementia With Lewy Bodies, Alzheimer Disease, Self, Autobiographical Memory, Insular Cortex
- Being tested
- Neuropsychological assessment and Multimodal brain MRI
- Medical subject headings
- Lewy Body Disease, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessment and Multimodal brain MRIOther
Neuropsychological assessment and Multimodal brain MRI
| Study group | Role | What they receive |
|---|---|---|
| dementia with Lewy bodies | Experimental | Not described Receives: Other: Neuropsychological assessment and Multimodal brain MRI |
| Alzheimer disease | Active comparator | Not described Receives: Other: Neuropsychological assessment and Multimodal brain MRI |
| healthy elderly subjects | Sham comparator | Not described Receives: Other: Neuropsychological assessment and Multimodal brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological assessment
Measured: months 3
Multimodal brain MRI
Measured: months 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start25 Jan 2021
- Primary completion14 Jun 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie PHILIPPI, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616287
- Sponsor's protocol ID
- 7942
- Acronym
- SELF-MCL
- Status last verified
- Sep 2025
- First submitted
- 2 Nov 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tisserand A, Philippi N, Botzung A, Blanc F. Me, Myself and My Insula: An Oasis in the Forefront of Self-Consciousness. Biology (Basel). 2023 Apr 14;12(4):599. doi: 10.3390/biology12040599.
PubMed 37106799
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self in Dementia With Lewy Bodies: a Behavioral and Multimodal Neuroimaging Study
- ClinicalTrials.gov ID
- NCT04616287
- Acronym / sponsor ID
- SELF-MCL / 7942
- Conditions
- Dementia With Lewy Bodies, Alzheimer Disease, Self, Autobiographical Memory, Insular Cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dementia with Lewy bodies | Experimental | Other: Neuropsychological assessment and Multimodal brain MRI |
| Alzheimer disease | Active comparator | Other: Neuropsychological assessment and Multimodal brain MRI |
| healthy elderly subjects | Sham comparator | Other: Neuropsychological assessment and Multimodal brain MRI |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (11 listed)
- Subjects with significant neuropsychiatric comorbidities
- Abnormal neurological examination
- Sensory impairment that may significantly interfere with testing
- Contraindication to MRI
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessment and Multimodal brain MRINeuropsychological assessment and Multimodal brain MRI | Other | Alzheimer disease, dementia with Lewy bodies, healthy elderly subjects |
Primary outcome
Neuropsychological assessment
Time frame: months 3
Multimodal brain MRI
Time frame: months 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 37106799Tisserand A, Philippi N, Botzung A, Blanc F. Me, Myself and My Insula: An Oasis in the Forefront of Self-Consciousness. Biology (Basel). 2023 Apr 14;12(4):599. doi: 10.3390/biology12040599.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie PHILIPPI, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological assessment and Multimodal brain MRI in people with Dementia With Lewy Bodies and Alzheimer Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological assessment (time frame: months 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.