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Brain study reveals how dementia changes your sense of self

NCT ID NCT04616287

Knowledge-focused Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how people with dementia with Lewy bodies experience their sense of self, including memory and self-concept. Researchers compared 61 participants with dementia, Alzheimer's, and healthy aging using memory tests and brain scans. The goal was to understand which brain changes cause these self-awareness problems, not to test a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

61 people

The number who actually took part.

Started

Jan 2021

Finished

Oct 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Lewy body dementia Lewy Body Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Autobiographical memory Dementia with lewy bodies Insular cortex SELF

Contacts and locations

Locations

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.