RecruitingDementia With Lewy BodiesParkinson Disease DementiaHealthy Controls
Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
Eligible age
50–89 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
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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
Sponsor: Virginia Commonwealth University
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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)
Where it's recruiting
Virginia
Richmond
Source: ClinicalTrials.gov · NCT07284290 · last updated 2026-03-06