Status:
COMPLETED
Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson Disease
Eligibility:
All Genders
50-99 years
Phase:
PHASE1
PHASE2
Brief Summary
This arm is a positron emission tomography (PET) biomechanistic GABA-A receptor target engagement study that includes detailed clinical and motor assessments before and after the i.v. administration o...
Detailed Description
This biomechanistic GABA-A receptor target engagement study includes clinical and motor assessments before and at various time points up to approximately 90 minutes after the i.v. administration of 1 ...
Eligibility Criteria
Inclusion
- Parkinson's disease (PD): PD diagnosis will follow the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD.
- Hoehn and Yahr stages 2-4
- Absence of dementia confirmed by cognitive testing.
- Abnormal 11C-Dihydrotetrabenazine (\[11C\]-DTBZ) PET study to demonstrate nigrostriatal dopaminergic denervation.
Exclusion
- PD with Dementia (PDD) or dementia with Lewy bodies (DLB).
- Other disorders which may resemble PD, such as vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia or appendicular apraxia, which may differentiate them from idiopathic PD. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
- Subjects on benzodiazepine, GABA-ergic medications (baclofen, tizanidine), neuroleptic, anticholinergic (trihexyphenidyl, benztropine), or cholinesterase inhibitor drugs.
- Evidence of a mass lesion on structural brain imaging (MRI).
- Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, chest, or cochlear implant.
- Severe claustrophobia precluding MR or PET imaging.
- Subjects limited by participation in research procedures involving ionizing radiation.
- Pregnancy (urine or serum pregnancy test within 48 hours of each PET session) or breastfeeding.
- History of seizures
- Significant anxiety or history of panic disorder.
- History of recent suicide attempt or overdose of tricyclic antidepressants or other medications
- Any other medical history determined by investigators to preclude safe participation.
- Allergy to flumazenil
- Significant liver disease
- History of alcohol or other substance abuse within past two years.
- History of regular benzodiazepine use within past year
Key Trial Info
Start Date :
March 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03462641
Start Date
March 9 2018
End Date
June 4 2021
Last Update
September 27 2022
Active Locations (1)
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1
University of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, United States, 48106