Dementia With Lewy BodiesPhase 4NCT07284290
Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
A Phase 4 study testing Syn-One skin biopsy, Multi modal MRI and Assessment of dynamic EEG features over 48-hour periods across all study aims in people with Dementia With Lewy Bodies and Parkinson Disease Dementia, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The proposed study aims to address the critical gaps in understanding the mechanisms of CF (Cognitive Fluctuations) by leveraging recently emerged molecular biomarkers, advanced neuroimaging techniques to assess measures of cholinergic degeneration, and synchronous EEG and assessments of attention. Read more about this study
- Who is it for?
- Ages 50 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia With Lewy Bodies, Parkinson Disease Dementia, Healthy Controls
- What is being tested?
- Syn-One skin biopsy, Multi modal MRI and Assessment of dynamic EEG features over 48-hour periods across all study aims
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to Nov 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 50 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
- 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.
- 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).
Who cannot join
- 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.
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- 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
- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Kara McHaney, (804) 828-4788, Kara.McHaney@vcuhealth.org
Matthew Barrett, MD
About this study
The proposed study aims to address the critical gaps in understanding the mechanisms of CF (Cognitive Fluctuations) by leveraging recently emerged molecular biomarkers, advanced neuroimaging techniques to assess measures of cholinergic degeneration, and synchronous EEG and assessments of attention. One of the overarching innovations of study is combining all of these assessments into one integrated research plan
Read the detailed description
Aim 1 is a cross-sectional case control study in which cholinergic degeneration in 45 participants with DLB or PDD with CF will be compared to a group of 45 individuals with Lewy Body disease without CF and 30 healthy controls. The first 20 participants who are eligible for Aim 2 and consent will also participate in an 8-week pre-post interventional cohort study immediately following Aim 1 procedures. For Aim 3, Aim 1 participants will complete annual follow-up evaluations for 2 years to understand factors influencing the change in cognitive fluctuations over time.
- Being tested
- Syn-One skin biopsy, Multi modal MRI, Assessment of dynamic EEG features over 48-hour periods across all study aims, Plasma biomarkers, Galantamine HBr extended-release 8mg capsules (8mg ER).
- Keywords
- Parkinson Disease with Mild Cognitive Impairment, Mild Cognitive Impairment with Lewy Bodies
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syn-One skin biopsyProcedure or surgery
Detects phosphorylated alpha synuclein in cutaneous nerve fibrils which has >95% sensitivity in detecting DLB
Multi modal MRIDiagnostic test
Functional MRI used to investigate the network connectivity changes associated with alterations in the cholinergic system. Using this comprehensive methodology to establish cholinergic degeneration's contribution to CF provides a robust framework for future research and therapeutic strategies.
Assessment of dynamic EEG features over 48-hour periods across all study aimsDiagnostic test
Implementing prolonged EEG monitoring, to capture dynamic changes in neural activity associated with CF. The methods are designed avoid the limitations identified in a systematic review of EEG studies in DLB, as will use quantitative analysis of EEG, uniformly apply diagnostic criteria, and consider the confounding effects of medications.
Concurrent evaluation of PVT performance and EEG This dual assessment will correlate cognitive and neurophysiological dynamics in real-time, providing a more holistic understanding of CF over time and the functional brain activity that underlies them. Temporal integration of PVT with EEG data collection will enable the identity of specific correlates of CF.
Plasma biomarkersDiagnostic test
A blood sample will be collected and sent for processing by C2N Diagnostics for the detection of Aβ42/40 and p-tau217 via mass spectrometry, a method shown to be highly accurate for predicting amyloid positivity on PET (AUC=0.94). Exploratory Biomarkers: The additional blood sample will be used for analysis of exploratory biomarkers and future research. A total of up to 20mL of blood will be taken.
Galantamine HBr extended-release 8mg capsules (8mg ER).Drug
20 participants from the arm 1. Participants will take 1 capsule daily of galantamine 8mg ER for 4 weeks and then increase to 2 capsules daily of galantamine 8mg ER (16mg) for 4 weeks. This titration will mitigate potential for cholinergic side effects. At 2 weeks, 4 weeks and 6 weeks of the treatment period, safety and compliance will be assessed during phone call visits. Any adverse event rated as Grade 2 or greater according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and that is definitely or possibly attributable to the study drug will result in study drug withdrawal or dose reduction.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with DLB or PDD | Experimental | 90 subjects with Dementia with Lewy Bodies (DLB) or Parkinson's Disease with Dementia (PDD) Receives: Procedure: Syn-One skin biopsy; Diagnostic Test: Multi modal MRI; Diagnostic Test: Assessment of dynamic EEG features over 48-hour periods across all study aims; Diagnostic Test: Plasma biomarkers |
| Subjects with Lewy Body disease with CF | Active comparator | A subset of 20 subjects with Lewy Body (LB) disease with Cognitive fluctuations (CF)
This arm will be a subset of 20 subjects from Arm #1 (Subjects with DLB or PDD). Receives: Diagnostic Test: Multi modal MRI; Diagnostic Test: Assessment of dynamic EEG features over 48-hour periods across all study aims; Drug: Galantamine HBr extended-release 8mg capsules (8mg ER). |
| Healthy control subjects | Other | 30 healthy controls Receives: Diagnostic Test: Multi modal MRI; Diagnostic Test: Assessment of dynamic EEG features over 48-hour periods across all study aims; Diagnostic Test: Plasma biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment of Fluctuations (CAF) (frequency and duration score)
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
Measured: Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit
Dementia Cognitive Fluctuations Scale-Research Version (DCFS-R) (total score)
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.
Measured: Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit
Mayo Fluctuations Scale (Four questions)
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.
Measured: Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit
Functional Activities Questionnaire (FAQ Assessment)
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.
Measured: Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
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.
Measured: Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit
REM Sleep Behavior Disorder Questionnaire (RBDSQ)
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.
Measured: Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit
Neuropsychiatric Inventory (NPI)
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.
Measured: Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit
Enhanced Scale for the assessment for Parkinson's Disease (SAPS-PD)
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".
Measured: Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit
Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start8 Dec 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A cross-sectional case control study in which cholinergic degeneration in 45 subjects with DLB or PDD with CF will be compared to a group of 45 subjects with Lewy Body disease without CF and 30 healthy controls. The first 20 participants who are eligible and consent will also participate in an 8-week pre-post interventional cohort study.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Barrett, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284290
- Sponsor's protocol ID
- HM20033370
- Other IDs
- R01NS142622
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
- ClinicalTrials.gov ID
- NCT07284290
- Acronym / sponsor ID
- HM20033370
- Keywords
- Parkinson Disease with Mild Cognitive Impairment, Mild Cognitive Impairment with Lewy Bodies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 16 Dec 2025 (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 proposed study aims to address the critical gaps in understanding the mechanisms of CF (Cognitive Fluctuations) by leveraging recently emerged molecular biomarkers, advanced neuroimaging techniques to assess measures of cholinergic degeneration, and synchronous EEG and assessments of attention. One of the overarching innovations of study is combining all of these assessments into one integrated research plan
Detailed description
Aim 1 is a cross-sectional case control study in which cholinergic degeneration in 45 participants with DLB or PDD with CF will be compared to a group of 45 individuals with Lewy Body disease without CF and 30 healthy controls. The first 20 participants who are eligible for Aim 2 and consent will also participate in an 8-week pre-post interventional cohort study immediately following Aim 1 procedures. For Aim 3, Aim 1 participants will complete annual follow-up evaluations for 2 years to understand factors influencing the change in cognitive fluctuations over time.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A cross-sectional case control study in which cholinergic degeneration in 45 subjects with DLB or PDD with CF will be compared to a group of 45 subjects with Lewy Body disease without CF and 30 healthy controls. The first 20 participants who are eligible and consent will also participate in an 8-week pre-post interventional cohort study.
| Arm | Type | Receives |
|---|---|---|
| Subjects with DLB or PDD | Experimental | Procedure: Syn-One skin biopsy, Diagnostic Test: Multi modal MRI, Diagnostic Test: Assessment of dynamic EEG features over 48-hour periods across all study aims, Diagnostic Test: Plasma biomarkers90 subjects with Dementia with Lewy Bodies (DLB) or Parkinson's Disease with Dementia (PDD) |
| Subjects with Lewy Body disease with CF | Active comparator | Diagnostic Test: Multi modal MRI, Diagnostic Test: Assessment of dynamic EEG features over 48-hour periods across all study aims, Drug: Galantamine HBr extended-release 8mg capsules (8mg ER).A subset of 20 subjects with Lewy Body (LB) disease with Cognitive fluctuations (CF) This arm will be a subset of 20 subjects from Arm #1 (Subjects with DLB or PDD). |
| Healthy control subjects | Other | Diagnostic Test: Multi modal MRI, Diagnostic Test: Assessment of dynamic EEG features over 48-hour periods across all study aims, Diagnostic Test: Plasma biomarkers30 healthy controls |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
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 |
|---|---|---|
| Syn-One skin biopsyDetects phosphorylated alpha synuclein in cutaneous nerve fibrils which has >95% sensitivity in detecting DLB | Procedure or surgery | Subjects with DLB or PDD |
| Multi modal MRIFunctional MRI used to investigate the network connectivity changes associated with alterations in the cholinergic system. Using this comprehensive methodology to establish cholinergic degeneration's contribution to CF provides a robust framework for future research and therapeutic strategies. | Diagnostic test | Healthy control subjects, Subjects with DLB or PDD, Subjects with Lewy Body disease with CF |
| Assessment of dynamic EEG features over 48-hour periods across all study aimsImplementing prolonged EEG monitoring, to capture dynamic changes in neural activity associated with CF. The methods are designed avoid the limitations identified in a systematic review of EEG studies in DLB, as will use quantitative analysis of EEG, uniformly apply diagnostic criteria, and consider the confounding effects of medications. Concurrent evaluation of PVT performance and EEG This dual assessment will correlate cognitive and neurophysiological dynamics in real-time, providing a more holistic understanding of CF over time and the functional brain activity that underlies them. Temporal integration of PVT with EEG data collection will enable the identity of specific correlates of CF. | Diagnostic test | Healthy control subjects, Subjects with DLB or PDD, Subjects with Lewy Body disease with CF |
| Plasma biomarkersA blood sample will be collected and sent for processing by C2N Diagnostics for the detection of Aβ42/40 and p-tau217 via mass spectrometry, a method shown to be highly accurate for predicting amyloid positivity on PET (AUC=0.94). Exploratory Biomarkers: The additional blood sample will be used for analysis of exploratory biomarkers and future research. A total of up to 20mL of blood will be taken. | Diagnostic test | Healthy control subjects, Subjects with DLB or PDD |
| Galantamine HBr extended-release 8mg capsules (8mg ER).20 participants from the arm 1. Participants will take 1 capsule daily of galantamine 8mg ER for 4 weeks and then increase to 2 capsules daily of galantamine 8mg ER (16mg) for 4 weeks. This titration will mitigate potential for cholinergic side effects. At 2 weeks, 4 weeks and 6 weeks of the treatment period, safety and compliance will be assessed during phone call visits. Any adverse event rated as Grade 2 or greater according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and that is definitely or possibly attributable to the study drug will result in study drug withdrawal or dose reduction. | Drug | Subjects with Lewy Body disease with CF |
Primary outcome
Clinical Assessment of Fluctuations (CAF) (frequency and duration score)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- 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.
Matthew Barrett principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Syn-One skin biopsy, Multi modal MRI and Assessment of dynamic EEG features over 48-hour periods across all study aims in people with Dementia With Lewy Bodies and Parkinson Disease Dementia, run by Virginia Commonwealth University at 1 site in United States.
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 23 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kara McHaney ((804) 828-4788, Kara.McHaney@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Assessment of Fluctuations (CAF) (frequency and duration score) (time frame: Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2026.