NeuralCipher Research overview
The text below is the source article’s original abstract under a verified reuse license. cc by
BackgroundParkinson's disease (PD) is a neurodegenerative condition with progressive phosphorylated alpha-synuclein (P-SYN) deposition. Skin biopsies are a sensitive and specific source of tissue to detect intra-axonal P-SYN in patients with PD. Further, isolated REM sleep behavior disorder (iRBD) is a prodromal condition with a high risk of phenoconversion to PD. The objective of the Synuclein-Quantification (Syn-Q) study is to quantify cutaneous P-SYN across a range of PD severity and in iRBD and measure changes in P-SYN over time.MethodsAfter consent, participants with iRBD and PD across Hoehn and Yahr stages 1, 2, 3 will complete neurological and cognitive evaluation, motor and olfactory assessments, orthostatic vitals, and questionnaires. Skin biopsies (3 mm diameter and 3-4 mm depth) will be taken from distal leg 10 cm above the lateral malleolus, distal thigh 10 cm above the lateral knee, and posterior cervical region 3 cm lateral to the C-7 spinous process with quantitation of cutaneous intra-axonal P-SYN. Participants will return for follow-up visits to repeat study procedures at 6, 12, and 18 months following the baseline visit. This study is funded by the Michael J. Fox Foundation and is registered on Clinicaltrial.org (NCT06621602).Expected resultsWe anticipate that patients with more severe stages of PD will have higher levels of quantitative P-SYN. We also predict that increases in P-SYN over time will be associated with worsening disease severity.DiscussionIn patients with PD, the detection and quantification of P-SYN is a critical step to supporting clinical trials that seek to alter the natural history of disease. Skin biopsies offer a more accessible, repeatable and quantifiable approach to monitoring phosphorylated alpha-synuclein compared to cerebrospinal fluid. This study will define the longitudinal rates of P-SYN change in patients with PD from prodromal to advanced disease.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT06621602.
Scientific assessment
Research question
Assess the question within the original study’s scope.
Methods & sample
Check the source article for study design and sample details.
Key findings
An editorially approved findings summary is not yet published for this record.
Limitations
Generalizability, bias and clinical meaning require separate assessment.
Methods, samples and clinical conclusions are not inferred from bibliographic metadata.