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
N/A
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 trial investigates cholinergic degeneration's role in cognitive fluctuations in people with Lewy Body Dementia (DLB) and Parkinson Disease Dementia (PDD). It aims to fill knowledge gaps by integrating biomarkers, advanced brain imaging, and EEG assessments to better understand these fluctuations. The study includes cross-sectional comparisons and long-term follow-ups to explore how cognitive fluctuations change over time. Participants include 45 individuals with DLB or PDD who have cognitive fluctuations, 45 Lewy Body disease patients without cognitive fluctuations, and 30 healthy controls. A subset of 20 participants will join an 8-week treatment phase with galantamine, starting with 8mg daily for 4 weeks, then increasing to 16mg daily. Safety and adherence will be checked through phone calls at 2, 4, and 6 weeks. Throughout the study, participants undergo assessments including skin biopsies, multimodal MRI, prolonged EEG monitoring, blood biomarker collection, and cognitive testing. Researchers will measure cognitive fluctuation severity using several scales at baseline, 56 days, and annual follow-ups over two years. Safety monitoring, neuropsychiatric inventories, and sleep behavior questionnaires are also included to track participant well-being and study effects.
CONDITIONS
Brief 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 less than 90 years
- Diagnosis of dementia with Lewy bodies, Parkinson disease dementia, Parkinson disease with Mild Cognitive Impairment, or Mild Cognitive Impairment with Lewy bodies
- For DLB, meeting clinically probable criteria based on 2017 consensus report
- For PDD, meeting clinically probable PD and probable PDD criteria
- Ability to provide informed consent or availability of a legal representative
- Availability of an informant for participants with dementia
- Ability and willingness to comply with study procedures
- Fluent in spoken and written English
- For cholinesterase inhibitor cohort: completed Aim 1, clinical diagnosis of LBD with cognitive fluctuations, not taking cholinesterase inhibitors in prior 90 days, and compliance ability
- Healthy controls aged 50 to less than 90 without neurological conditions affecting study
You will not qualify if you...
- History of cognitive or psychiatric disorder unrelated to DLB or PDD
- History of deep brain stimulation or neurosurgical procedures
- History of structural brain disease or significant cerebrovascular disease
- History of seizures, epilepsy, or use of certain sodium channel blockers
- More than two alcoholic drinks daily for men, more than one for women
- Regular use of benzodiazepines or barbiturates (with restrictions on timing)
- Severe dementia based on dependence level
- Contraindication to brain MRI
- Medical conditions interfering with study procedures
- Pregnancy or planning to become pregnant or father a child during study
- For cholinesterase inhibitor cohort: severe liver impairment, renal failure, significant bradycardia or AV block, contraindications to galantamine
- Healthy controls with any neurological or psychiatric disorders affecting study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day to 1 week depending on scheduling
Participants undergo diagnostic tests including Syn-One skin biopsy, multi modal MRI, plasma biomarker blood draws, and 48-hour EEG monitoring to assess cholinergic degeneration and cognitive fluctuations.
1 to 3 visits (in-person)
Duration - 8 weeks
Participants in the cholinesterase inhibitor cohort take galantamine 8mg extended-release capsules once daily for 4 weeks, then increase to 16mg daily for 4 weeks with safety and compliance phone call visits at weeks 2, 4, and 6.
1 baseline visit (in-person) and 3 phone call visits
Duration - 2 years
Participants complete annual follow-up evaluations for 2 years to understand factors influencing changes in cognitive fluctuations over time.
2 visits (in-person) at 1 year and 2 year follow-up
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
K
Kara McHaney
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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