Parkinson's Disease Parkinson's disease
Conditions
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Prior to enrollment in this clinical investigation, candidates must meet ALL of the following criteria:* Subject has Parkinson's disease of <=5 years duration, defined as time since diagnosis made by a neurologist. * Subject is an adult, at least 18 years of age. * Subject can read and understand Dutch. * Subject has completed the CMO-approved Informed Consent. * Subject is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collection. * Subject is not a current or previous employee or family member of employees of the institutions involved in the study, including Verily Life Sciences and Radboudumc.
Exclusion criteria
Exclusion criteria: Candidates must be excluded from this study if ANY of the following criteria are met:* Subject is pregnant or breastfeeding. * Subject has co-morbidities that would hamper interpretation of parkinsonian disability, such as coincident musculoskeletal abnormalities, in the opinion of the Investigator. * Contraindicated for MRI, e.g. claustrophobia, presence of an active implant, pacemaker, insulin pump, neurostimulator, ossicle prosthesis, and/or other medical device or other non-removable metal part incompatible with MRI. * For lumbar puncture: o Allergy to local anesthetic agents o Medical history of compression of spinal cord, current local skin infection at the site of the lumbar puncture, developmental abnormalities in lower spine, blood coagulopathy, anticoagulant medication (Acenocoumarol, Warfarin, Dabigatran). o Clinical (or previous MRI) evidence of structural cerebral abnormalities that are not compatible with the performance of a lumbar puncture such as malignancies, abscess, or obstructive hydrocephalus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinimetrics (on site, by assessor): - Motor Assessment Subset OFF Medication: Hoehn & Yahr stage; UPDRS-III (Including timed up-and-go tests to assess gait); UPDRS-IV; Standing leg / flamingo Test; Pirouette Test; Pegboard Test; Grip strength. - Motor Assessment Subset ON Medication: Hoehn & Yahr stage; UPDRS-II; UPDRS-III (Including timed up-and-go tests to assess gait); UPDRS-IV; Freezing of Gait Questionnaire; Standing leg / flamingo Test; Pirouette Test; Pegboard Test; Grip strength. - Neuropsychological Symptoms: UPDRS-I; Montreal Cognitive Assessment; Phonemic Fluency Semantic Fluency; 15 Words Test; Benton Judgment of Line Orientation; Letter Number Sequencing; Symbol Digit Modalities Test. Vragenlijsten voor patiënt: - Neuropsychological symptoms: Beck Depression Inventory; Quip- RS (impulsive compulsive disorder); Apathy scale; Trait Anxiety Inventory for Adults; - Other UPDRS-II;: SCOPA- autonomic; SCOPA- sleep; RBD questionnaire; Epworth sleep questionnaire; SF-12; Wearing-off questionnaire; Radboud Oral Motor Inventory; Screening Questionnaire on Visual Impairment; Diet - 24h web based self-report (developed by Wageningen University) - Only at T4: UPSIT smell-test, GIDS-PD. Biomarkers * Imaging - MRI: volumetrics, DTI, resting state - ECG: heart rate variability * Biospecimens - Blood: Plasma / PBMCs serum, EDTA plasma (DNA), PAXgene (RNA) - CSF: Tau, urate - StoolOptional assessments at T4: 2min overground walking with/without dual-taskspeech analysesBIA-measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| Study Watch Data collection: • Pulse rate • Skin temperature, Electrodermal activity (sweat) • Movement data (Accelerometer) • Electrocardiogram (ECG) • Altitude, pressure, relative humidity • Environment temperature • Ambient light level • Sound pressure level | — |
Countries
Netherlands
Contacts
Public ContactJJP Rigters-Schimmel
Radboud Universitair Medisch Centrum
Outcome results
None listed