Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia

Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 89
Healthy Volunteers: t
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⁃ 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)

⁃ 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).

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Madison Clemons
Madison.Clemons@vcuhealth.org
(804) 827-1754
Backup
Kara McHaney
Kara.McHaney@vcuhealth.org
Time Frame
Start Date: 2026-01-25
Estimated Completion Date: 2029-11
Participants
Target number of participants: 120
Treatments
Experimental: Subjects with DLB or PDD
90 subjects with Dementia with Lewy Bodies (DLB) or Parkinson's Disease with Dementia (PDD)
Active_comparator: Subjects with Lewy Body disease with CF
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).
Other: Healthy control subjects
30 healthy controls
Sponsors
Leads: Virginia Commonwealth University
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov