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Understanding Cognitive Fluctuations in Lewy Body Dementia

This study is looking at how changes in a brain chemical system (cholinergic degeneration) contribute to cognitive fluctuations (changes in thinking and alertness) in people with Lewy Body Dementia (DLB) and Parkinson's Disease Dementia (PDD). Researchers will use a skin biopsy (Syn-One) to detect a specific protein, advanced MRI scans, and prolonged EEG monitoring (brain wave tests) to understand these changes. They will also collect blood samples for biomarkers (substances that indicate disease). A small group of participants will also take galantamine HBr extended-release capsules (a medication for dementia) for 8 weeks. The study aims to understand what causes these fluctuations and how they change over time. You may be eligible if you are 50 to 89 years old and have been diagnosed with DLB, PDD, or related conditions. The study is currently recruiting participants.

Study design
This interventional study plans to enroll 120 participants, including those with Lewy Body Dementia, Parkinson's Disease Dementia, and healthy controls. It involves a cross-sectional comparison, an 8-week interventional cohort for some participants, and a 2-year follow-up.
What's involved
Participants will undergo a skin biopsy, multi-modal MRI, 48-hour EEG monitoring, and blood draws. Some participants will take galantamine HBr extended-release capsules daily for 8 weeks. Assessments will occur at screening, baseline, day 56 for the medication group, and then annually for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will have follow-up visits at 1 year and 2 years after their initial assessments to track changes in cognitive fluctuations.

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NCT07284290

Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia

Recruiting
PHASE4Ages 50–89InterventionalBasic science
Virginia Commonwealth University
~120 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:Syn-One skin biopsyMulti modal MRIAssessment of dynamic EEG features over 48-hour periods across all study aimsPlasma biomarkersGalantamine HBr extended-release 8mg capsules (8mg ER).

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Assessment of Fluctuations (CAF) (frequency and duration score)
Measured over Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit
+8 more outcomes measured

Conditions

Dementia With Lewy Bodies
Parkinson Disease Dementia
Healthy Controls

Explore related trials

Dementia associated with Parkinson's DiseaseHealthy ControlsLewy Body DementiaMild cognitive disorderParkinson Disease

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Matthew Barrett · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Kara McHaney
[email protected]
(804) 828-4788
Email the study team

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Eligibility criteria

Inclusion

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)
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.
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

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
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.
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

What this trial measures

  • Clinical Assessment of Fluctuations (CAF) (frequency and duration score)Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit

    The scoring for the Clinical Assessment of Fluctuations (CAF) is a two-step process that uses both a frequency and a duration score. The two scores are multiplied together to get the final severity rating. A higher score indicates more severe cognitive fluctuations. After rating the frequency and duration, the two scores are multiplied to get the final CAF score. Frequency score x Duration score=Total CAF score

  • Dementia Cognitive Fluctuations Scale-Research Version (DCFS-R) (total score)Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit

    The DCFS-R is measured as a total score from 4 to 20, with higher scores indicating more severe cognitive fluctuations in dementia. It is calculated by summing a nurse's ratings on four items, each scored on a 5-point Likert scale (1=no difference, 5=very large difference). The four items assess the difference between a person's best and worst functioning, which includes daytime somnolence, drowsiness, and altered levels of consciousness.

  • Mayo Fluctuations Scale (Four questions)Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit

    The four questions included in the Mayo Fluctuations Scale have been found to significantly differentiate Alzheimer's Disease from DLB. Positive items are summed to create a "fluctuations composite score" with a score of 3 or 4 associated with DLB.

  • Functional Activities Questionnaire (FAQ Assessment)Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

    The FAQ is a number from 0 to 30 that represents a person's independence in daily tasks, with higher scores indicating more difficulty. The score is calculated by summing the ratings (0-3) for 10 activities, and a cut-off score of 9 or higher is often used to suggest potential cognitive or functional impairment.

  • Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

    The MDS-UPDRS is a tool that measures the experiences of daily living (Part I), motor experiences of daily living (Part II), motor examination (Part III), and motor complications (Part IV). Scores range from 0 to 260, with 0 indicating no disability and higher scores indicating greater disability. The individual parts are rated on a scale of 0 to 4, with higher scores indicating greater impairment.

  • REM Sleep Behavior Disorder Questionnaire (RBDSQ)Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

    The RBDSQ is measured by a total from 0-13, with a score of 5 or higher indicating a positive result for REM Sleep Behavior Disorder (RBD). The questionnaire is a 10-item self-rating tool to screen for RBD, and the cutoff score can vary depending on the population being screened.

  • Neuropsychiatric Inventory (NPI)Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

    The NPI is an interview performed with a caregiver to assess any changes in the participants' behavior related to delusions, hallucinations, anxiety, and apathy. It is comprised of 4 main questions, 31 sub-questions and frequency/severity ratings.

  • Enhanced Scale for the assessment for Parkinson's Disease (SAPS-PD)Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

    The eSAPS-PD is used to measure the severity of hallucinations and delusions in patients with Parkinson's Disease Psychosis (PDP). Scored on a scale of 0 to 5 for each of its 9 items, resulting in a total score from 0 to 45. Each item is rated based on the severity of the symptom, with a score of 0 meaning "None" and a score of 5 meaning "Severe".

  • Patient Health Questionnaire-9 (PHQ-9)Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

    The PHQ-9 is a self-report measure used to screen for and assess the severity of depression in adults. It consists of nine questions based on the diagnostic criteria for major depressive disorder in the DSM-5. The total score for the PHQ-9 can range from 0 to 27. Each of the nine items is scored based on the frequency with which a person has experienced a specific symptom over the past two weeks: 0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day. The scores for all nine items are added together to produce a total severity score. While scores of 10 or higher have high sensitivity and specificity for identifying major depression, the PHQ-9 alone is not a diagnostic tool. A clinical interview is necessary for a definitive diagnosis.