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New study aims to unlock mystery of 'Brain Fog' in lewy body dementia

NCT ID NCT07284290

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at why people with Lewy body dementia have sudden changes in attention and thinking, called cognitive fluctuations. Researchers will use skin biopsies, brain scans, and EEG monitoring in 120 participants to link these symptoms to damage in a key brain chemical system. The goal is to better understand the disease, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal why people with Lewy body dementia experience sudden changes in attention and thinking, pointing toward future treatments.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve symptoms, and results may take years to influence care.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

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

50 to 89 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: Arm 1: * Age range: 50 ≤ age \< 90. * Diagnosis of dementia with Lewy bodies (DLB), Parkinson disease dementia (PDD), Parkinson disease with Mild Cognitive Impairment (PD-MCI), Mild Cognitive Impairment with Lewy bodies (MCI-LB). * DLB participants must fulfill criteria for clinically probable DLB based on the 2017 4th consensus report of the DLB consortium. * PDD participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and must also meet criteria for probable PDD based on the 2007 Movement Disorders Society clinical diagnostic criteria. * PD-MCI participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and meet criteria for Mild Cognitive Impairment on cognitive testing at screening. * MCI-LB participants with must meet established research criteria. * Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent. * Availability of informant (for participants meeting criteria for dementia). * Ability and willingness to comply with the study-related procedures. * Fluent in spoken and written English (due to cognitive testing) Exclusion Criteria: Arm 1 * History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia. * History of deep brain stimulation or any neurosurgical procedure. * History of structural brain disease or known significant cerebrovascular disease. * History of seizures or epilepsy and/or use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate. * Greater than two alcoholic drinks per day for men and one per day for women. * Regular use of benzodiazepines or barbiturates. (If benzodiazepines are taken as needed only, these medications cannot be taken within 5 half-lives of screening visit or between screening visit and EEG.) * Severe dementia (based on PI assessment of subject dependence level for instrumental activities of daily living) * Any contraindication to brain MRI. * Any medical condition that would interfere with ability to complete all study procedures. * Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study Inclusion Criteria: Arm 2 (Cholinesterase inhibitor cohort) inclusion criteria: * Completed Aim 1. * Clinical diagnosis of LBD (DLB or PDD) with CF. * Not taking a cholinesterase inhibitor and has not taken a cholinesterase inhibitor in the previous 90 days. * Ability and willingness to comply with the ChEI Cohort procedures (including galantamine administration), or a caregiver willing and able to ensure compliance. Exclusion Criteria: Arm 2 (Cholinesterase inhibitor cohort) exclusion criteria: * Severe hepatic impairment. * Renal failure. * Significant bradycardia (\<50 bpm) at screening or history of AV block. * Any contraindication to galantamine administration based on PI discretion. Inclusion criteria: Arm 3 (Healthy Controls) * Age range: 50 ≤ age \< 90. * Healthy controls should not have any known neurologic conditions that could interfere with study procedures or results. * Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent. * Availability of informant (for participants meeting criteria for dementia). * Ability and willingness to comply with the study-related procedures. * Fluent in spoken and written English (due to cognitive testing). Exclusion Criteria: Arm 3 (Healthy Controls) * No History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia. * No History of deep brain stimulation or any neurosurgical procedure. * No History of structural brain disease or known significant cerebrovascular disease. * No History of seizures or epilepsy and/or use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate. * Any medical condition that would interfere with ability to complete all study procedures. * Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

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