Actively Recruiting
Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
Led by Virginia Commonwealth University · Updated on 2026-03-06
120
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 89 years old.
- Diagnosis of dementia with Lewy bodies, Parkinson disease dementia, Parkinson disease with mild cognitive impairment, or mild cognitive impairment with Lewy bodies.
- DLB participants must meet criteria for probable DLB based on the 2017 consensus report.
- PDD participants must meet criteria for probable PD and probable PDD based on established clinical diagnostic criteria.
- PD-MCI participants must meet criteria for probable PD and mild cognitive impairment on screening cognitive tests.
- MCI-LB participants must meet established research criteria.
- Ability to provide informed consent or have a legally authorized representative or guardian who can consent.
- Availability of an informant for participants with dementia.
- Willingness and ability to comply with study procedures.
- Fluent in spoken and written English.
- For Arm 2 (Cholinesterase inhibitor cohort): Completed Aim 1, clinical diagnosis of LBD with cognitive fluctuations, not taking or have taken cholinesterase inhibitors in the past 90 days, and compliance ability with study procedures.
- For Arm 3 (Healthy Controls): Age 50-89, no known neurologic conditions affecting study participation, ability to consent, availability of informant if dementia present, willingness and ability to comply with procedures, fluent in English.
You will not qualify if you...
- History of cognitive or psychiatric disorders unrelated to dementia with Lewy bodies or Parkinson disease dementia.
- History of deep brain stimulation or any neurosurgical procedure.
- History of structural brain disease or significant cerebrovascular disease.
- History of seizures, epilepsy, or use of sodium channel blockers (e.g., carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, valproate).
- More than two alcoholic drinks per day for men or more than one per day for women.
- Regular use of benzodiazepines or barbiturates (with restrictions around screening and EEG).
- Severe dementia as assessed by dependence in daily living activities.
- Contraindications to brain MRI.
- Medical conditions interfering with study procedures.
- Pregnancy, planning to become pregnant, or fathering a child during the study.
- For Arm 2 (Cholinesterase inhibitor cohort): Severe liver impairment, kidney failure, significant slow heart rate (<50 bpm) or AV block, and contraindications to galantamine as determined by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
K
Kara McHaney
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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