Superior Cervical Ganglion in Parkinson's Disease

NCT05741151 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phase

Not applicable

Started

2023-01-01

Last updated

2023-03-01

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

PET-Neck Parkinsonian patients

PET-Neck Parkinsonian patients: Brain and neck PET-CT scan with 68Ga-PSMA to detect metabolism in the Superior Cervical Ganglion of both sides.

Study summary

In several neurodegenerative diseases, such as Parkinson's disease, the progressive loss of neurons of monoaminergic systems leads to the development of characteristic clinical manifestations.

Therefore, since the discovery that neurodegenerative phenomena are the basis of these Central Nervous System (CNS) diseases, re-innervation strategies have been studied that would allow to stop or at least slow down neurodegenerative phenomena, restoring lost catecholaminergic transmission.

Cell therapy in Parkinson's disease aims to treat motor disorders, but should not affect cognitive disorders that result from pathological alterations external to CNS and affecting other transmission systems, such as noradrenergic and cholinergic. These limitations lead to the search for new approaches based on the use of different cell types, but currently these scenarios still seem far away.

The theme of cerebral re-innervation in the treatment of neurodegenerative diseases is at the center of numerous translational and clinical research studies, developed according to various approaches and models, which testify to all the complexity and charm of the subject. Among the possible sources for a catecholamine reinnervation in Parkinson's disease, Superior Cervical Ganglion (SCG) could represent a valid autologous source: however, there is no functional evaluation in the literature that expresses the involvement or not of the ganglion in the neurodegenerative process.

This clinical study project is the first and essential phase of a larger project aimed at verifying the possibility of autologous catecholamine reinnervation in degenerative diseases of the CNS using the peripheral catecholamine system and in particular the superior cervical ganglion (GCS).

The aim of this project is to evaluate whether the peripheral catecholaminergic system, and in particular the SCG, is involved in the process of neurodegeneration. For this purpose, for an "in vivo" functional study, the suitability of the PET-CT 68Ga-PSMA examination will be studied in particular.

Eligibility

Sex

ALL

Min age

30 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Patients affected with Parkinson Disease according to the criteria defined by the Movements Disorder Society Exclusion Criteria: * Unambiguous cerebellar abnormalities, such as cerebellar gait, limb ataxia, or cerebellar oculomotor abnormalities (eg, sustained gaze-evoked nystagmus, square wave macro jerks, hypermetric saccades) * Palsy of vertical descending supranuclear gaze or selective slowing of vertical descending saccades * Diagnosis of probable behavioral variant of frontotemporal dementia or primary progressive aphasia, defined according to consensus criteria, within the first 5 years of the disease * Parkinsonian features limited to the lower limbs for more than 3 years * Treatment with a dopamine receptor blocker or dopamine-reducing agent at a dose and time consistent with drug-induced parkinsonism * Absence of observable response to high-dose levodopa despite at least moderate disease severity * Unequivocal cortical sensory deficit (i.e., graphesthesia, stereognosis with intact primary sensitivities), clear ideomotor apraxia of limbs, or progressive aphasia * Normal functional neuroimaging of the presynaptic dopaminergic system * Documentation of an alternative condition known to induce parkinsonism and plausibly related to the patient's symptoms, or, expert medical opinion that, based on the full diagnostic evaluation, believes that an alternative syndrome is more likely than Parkinson Disease

Primary outcome measure(s)

Capacity of the Superior Cervical Ganglion in parkinsonian patients — through study completion, an average of 3 years
The capacity of the Ganglion would be assessed through the analysis of degree of captation (68Ga-CTPET)

Trial sites (1)

Facility	City	Region	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05741151 on ClinicalTrials.gov ↗ ← All trials in Italy