Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm

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Recruiting
participants needed

30
sponsor

Nicolaas Bohnen, MD, PhD

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Updated on 19 February 2024

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anxiety

antidepressants

antipsychotics

stroke

serum pregnancy test

spinal cord

positron emission tomography

anticholinergics

brain imaging

parkinson's disease

parkinsonism

cholinesterase inhibitors

modafinil

dementia

cochlear implant

trihexyphenidyl

benztropine

Summary

The arm of this study evaluates possible GABA-A receptor target engagement effects of the FDA-approved medication, transdermal flumazenil (added 4/2020, replaced clarithromycin), in the setting of Parkinson's disease. Half of the subjects will receive transdermal flumazenil for 7-10 days, and half will receive a placebo. [11C]Flumazenil GABA-A receptor PET imaging will be used to assess target engagement effects.

Description

This study focuses on neurochemical changes in the brain that occur in Parkinson's disease. In particular we will be looking a neurotransmitter called GABA. In some Parkinson's disease patients we see too much GABA activity in the brain. This target engagement study examines the target engagement effect of GABA-A receptor modulation by transdermal flumazenil (previously clarithromycin). [11C]-flumazenil Positron Emission Tomography (PET) imaging results will be used to assess for possible GABA-A receptor target engagement effects of transdermal flumazenil (previously clarithromycin).

Details

Condition	Parkinson's Disease, Parkinson's Disease
Age	50-100 years
Treatment	Clarithromycin (Not used as of 4/2020), Placebo (Not used as of 4/2020), Transdermal flumazenil (Added 4/2020), Placebo (Added 4/2020)
Clinical Study Identifier	NCT03440112
Sponsor	Nicolaas Bohnen, MD, PhD
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 Criteria
	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 currently on benzodiazepine, GABAB-ergic medications (baclofen, tizanidine), modafinil, 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
	History of transient ischemic attack (TIA) or stroke within the last year
	History of systemic lupus erythematosis
	Abnormal liver enzymes (AST or ALT) > 3 times upper limit of normal
	History of atrial fibrillation
	History of retinal branch artery occlusion
	Active dermatitis inner forearms
	Any other medical history determined by investigators to preclude safe participation
	Additional Exclusion Criteria for Flumazenil sub-studies
	Allergy to flumazenil
	Significant liver disease
	History of alcohol or other substance abuse within past two years
	Subjects currently taking benzodiazepines

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Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm