Clinical trial NCT04264273: Diagnosis of Parkinson´s Disease by Means of Submandibular Gland Needle Biopsy
Official title: Intra Vitam Diagnosis of Parkinson´s Disease by Means of Submandibular Gland Needle Biopsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Alpha synuclein
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unselected cohort of PD patients

Brief summary: This study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls.

Detailed description: Parkinson´s disease (PD) is a neurodegenerative disease which is characterized by a pathological aggregation of α-synuclein. This pathological α-synuclein aggregation results in the formation of Lewy bodies which are used for the histopathological diagnosis of PD. Neuropathological post mortem studies showed that pathological aggregations of α-synuclein may occur also outside the central nervous system in PD, for example in the cardiac plexus, in the major salivary glands and the innervating cervical superior ganglion, in the minor salivary glands, in the adrenal glands and in the mesenteric and pelvic plexus. The finding of pathologically aggregated α-synuclein in the major salivary glands offers the possibility to prove PD intra vitam by means of a small transcutaneous biopsy.

A recent post mortem study in the local Department of Neuropathology found, that there was pathologically aggregated α-synuclein in 12 of 14 patients with diagnosed and neuropathologically confirmed PD, whereas there was no pathologically aggregated α-synuclein in 13 persons without PD.

The present study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls. Immediately after the biopsy, the obtained submandibular gland tissue is transported to the local Department of Neuropathology for histopathological analysis.

Eligibility criteria: Inclusion Criteria: major patients with Parkinson´s disease (PD)

Exclusion Criteria:

* Missing consent to participation in the study
* Pregnancy
* Indigestibility against local anesthetic
* Increased risk of bleeding
* Therapy with an anticoagulant

Primary outcomes:
measure: Pathologically aggregated α-synuclein in the submandibular gland.
timeFrame: only baseline, no further investigations.
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: Department of Neurology, Saarland University
state: Saarland
Study officials:
affiliation: Department of Neurology, Saarland University, D-66421 Homburg/Saar, Germany
name: Jörg Spiegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adler CH, Dugger BN, Hentz JG, Hinni ML, Lott DG, Driver-Dunckley E, Mehta S, Serrano G, Sue LI, Duffy A, Intorcia A, Filon J, Pullen J, Walker DG, Beach TG. Peripheral Synucleinopathy in Early Parkinson's Disease: Submandibular Gland Needle Biopsy Findings. Mov Disord. 2016 Feb;31(2):250-6. doi: 10.1002/mds.26476. Epub 2016 Jan 22.
citation: Beach TG, Adler CH, Dugger BN, Serrano G, Hidalgo J, Henry-Watson J, Shill HA, Sue LI, Sabbagh MN, Akiyama H; Arizona Parkinson's Disease Consortium. Submandibular gland biopsy for the diagnosis of Parkinson disease. J Neuropathol Exp Neurol. 2013 Feb;72(2):130-6. doi: 10.1097/NEN.0b013e3182805c72.
citation: Del Tredici K, Hawkes CH, Ghebremedhin E, Braak H. Lewy pathology in the submandibular gland of individuals with incidental Lewy body disease and sporadic Parkinson's disease. Acta Neuropathol. 2010 Jun;119(6):703-13. doi: 10.1007/s00401-010-0665-2. Epub 2010 Mar 14.
citation: Orimo S, Uchihara T, Nakamura A, Mori F, Kakita A, Wakabayashi K, Takahashi H. Axonal alpha-synuclein aggregates herald centripetal degeneration of cardiac sympathetic nerve in Parkinson's disease. Brain. 2008 Mar;131(Pt 3):642-50. doi: 10.1093/brain/awm302. Epub 2007 Dec 13.
citation: Spillantini MG, Schmidt ML, Lee VM, Trojanowski JQ, Jakes R, Goedert M. Alpha-synuclein in Lewy bodies. Nature. 1997 Aug 28;388(6645):839-40. doi: 10.1038/42166. No abstract available.