NCT07284290 Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
| NCT ID | NCT07284290 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Virginia Commonwealth University |
| Condition | Dementia With Lewy Bodies |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-12-08 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. One of the overarching innovations of study is combining all of these assessments into one integrated research plan
Eligibility Criteria
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
Contact & Investigator
Matthew Barrett
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT07284290 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 89 Years, studying Dementia With Lewy Bodies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07284290 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07284290 currently recruiting?
Yes, NCT07284290 is actively recruiting participants. Contact the research team at Kara.McHaney@vcuhealth.org for enrollment information.
Where is the NCT07284290 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT07284290 clinical trial?
NCT07284290 is sponsored by Virginia Commonwealth University. The principal investigator is Matthew Barrett at Virginia Commonwealth University. The trial plans to enroll 120 participants.