Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-89
SponsorVirginia Commonwealth University
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Syn-One skin biopsy
- Multi modal MRI
- Assessment of dynamic EEG features over 48-hour periods across all study aims
- Plasma biomarkers
- Galantamine HBr extended-release 8mg capsules (8mg ER).
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Virginia Commonwealth University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov