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STRAT-PARK

A CLINICAL COHORT INITIATIVE TO STRATIFY PD

Recruiting: YES
ClinicalTrials.gov ID: not registered
Ethics approval body/ID: REK / 74985
Type of study: longitudinal cohort, observational study
Single/multi-center: multi-center
Participating countries: Norway, Canada

RATIONAL/HYPOTHESIS

The heterogeneity of Parkinson ́s disease (PD) is a major obstacle preventing the development of patient-tailored therapies. Here, we aim to stratify PD by identifying and characterizing subgroups of patients with distinct clinical and/or molecular characteristics. Moreover, we aim to develop biomarkers enabling patient stratification in clinical practice.

We will establish a population-based cohort from three centres across Norway and Canada. We will follow the cohort yearly and map the longitudinal change of the molecular landscape in clinically accessible tissues of patients and controls. This will elucidate molecular processes implicated in disease initiation and progression and provide an early, crude clustering of patients according to molecular background. Subsequently, we will apply state-of-the-art computational analyses to perform multidimensional integration of our database and identify biomarkers for molecular stratification of PD. Biomarkers will be validated in other appropriate cohorts and assessed for innovation and commercialization potential. Successful biomarkers will enable patient selection for participation in tailored trials.

INCLUSION CRITERIA

The following inclusion criteria apply:

Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for Parkinson’s disease

FP-CIT single-photon emission CT (DaTscan) confirming nigrostriatal degeneration

Hoehn and Yahr score ≤ 4 at enrolment


Capacity to provide written informed consent for study participation.

Age 30-100 years

EXCLUSION CRITERIA

Comorbidity that precludes study participation.

DESIGN

The STRAT-PARK study represents a vast clinical endeavour, co-led by Neuro-SysMed PIs Charalampos Tzoulis in Norway and Mandar Jog in Canada. A total of 1,500-2,000 patients and controls will be recruited from three clinical centres: Haukeland University Hospital (HUS) in Bergen, St. Olavs University Hospital in Trondheim and The London Movement Disorders Centre (LMDC), Ontario, Canada. Subjects will be followed at yearly visits with repeated clinical investigations, neuroimaging, blood and cerebrospinal fluid sampling and muscle biopsy. We are particularly interested in the muscle specimens as this is a post-mitotic tissue that may express epigenetic, mitochondrial and other molecular markers of disease that are undetectable in blood. As part of our clinical characterization, we will implement novel methods of objective motor assessment using body suits with integrated movement sensors, implemented in collaboration with co-PI Prof. Mandar Jog, who is a leading world expert in motion biomechanics for PD and related movement disorders.

START DATE

Start date for enrolment: 01 January 2021

END DATE

Expected end date: 31 December 2050

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