Objective: To describe the study protocol of the Vall d’Hebron Initiative for Parkinson (VHIP) cohort, a prospective, longitudinal and observational cohort study aimed at deeply phenotyping de novo PD patients and carriers of PD-linked mutations. We anticipate this initiative will contribute to identify biomarkers for PD risk, diagnosis and prognosis, as well as to stratify disease subtypes and increase our understanding of pathophysiology at early PD stages.

Background: PD is a progressive neurodegenerative disorder causing a variety of motor and non-motor symptoms. To date, no disease-modifying treatment exists and diagnosis is based on the manifestation of the clinical motor symptoms, which occurs when the neurodegenerative process is already advanced. Studies designed to find diagnostic/prognostic biomarkers and pathophysiological pathways involved in disease onset/progression are needed.

Method: Participants involving 150 de novo subjects and 150 aged- and sex-matched healthy controls are estimated to be recruited by the movement disorders specialists at the Vall d’Hebron University Hospital (Barcelona). After informed consent, subjects are evaluated to primarily assess objectives within four major domains of PD: motor, cognitive-affective, autonomic function and vision. First, an extensive clinical evaluation is performed by (i) recording demographic, personal history, lifestyle and dietary habits, and by (ii) completing clinical scales covering motor and non-motor symptoms. Second, data from autonomic function and visual function tests, together with neuroimaging data, are acquired. Finally, a wide range of biospecimens such as blood, cerebrospinal fluid, urine, feces, oral and olfactory mucosa, and skin biopsy are collected for biochemical and molecular assessments, including the genotyping of all participants. Participants will receive follow-up assessments at 2.5 and 5-year intervals.

Results: VHIP is the first study to establish a Spanish cohort combining clinical, imaging, biochemical and molecular data in de novo patients and PD-linked mutation carriers over time.

Conclusion: VHIP provides a unique opportunity to link pre-diagnosis disturbances to PD development, as well as to identify risk, diagnosis and prognosis biomarkers.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/the-vall-dhebron-initiative-for-parkinson-vhip-cohort-a-prospective-longitudinal-and-observational-study-enrolling-de-novo-parkinsons-disease-pd-patients-and-carriers-of-pd-lin/