Parkinson's disease
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC, location VUmc
Eligibility
Inclusion criteria
Inclusion criteria: Patients In order to be eligible to participate in this study, a patient must meet ALL of the following criteria: - Recently diagnosed with PD (N=625; time since Parkinson diagnosis = 2 years) or not recently diagnosed with PD (N=625; time since Parkinson diagnosis > 2 & = 10 years) (Time since Parkinson diagnosis (in years) made by a neurologist according to the Movement Disorder Society clinical diagnostic criteria for Parkinson's disease; In order to obtain a good representation of the PD population an even distribution with respect to gender and age (age categories: 65 years) in both patient groups, will be attempted; - 18 years or older; - Able to read and understand Dutch; - Providing IRB-approved Informed Consent; - Willing, competent and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collections. Controls - 18 years or older; - Healthy (self-report); - Similar distribution with respect to gender and age as the patient groups will be attempted; - Providing IRB-approved Informed Consent; - Willing, competent and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collections.
Exclusion criteria
Exclusion criteria: A potential participant who meets ANY of the following criteria will be excluded from participation in this study: Patients - Patients who received brain surgery for Parkinson’s disease, patients who currently use levodopa continuous intestinal gel or patients who are currently receiving apomorphine treatment. - Presence of co-morbidities that would hamper interpretation of parkinsonian disability, in the opinion of the investigator; - MoCa score of =16 (indicates dementia); - Unwillingness to be informed of unexpected medical findings; - Note: patients with a disease duration of = 2 yrs, are excluded if: - they are current, recent or past participant in The Personalized Parkinson Project (“de Parkinson op maat studie”) from Radboudumc. - Patients with a disease duration of > 2 & = 10 yrs, are only excluded if they are currently a participant in The Personalized Parkinson Project (“de Parkinson op maat studie”) from Radboudumc. Controls - A history of neurological disorders that affect the brain or central nervous system; - Abnormal findings at general neurological examination; - Unwillingness to be informed of unexpected medical findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main clinical outcomes related to characterization of ADRs The main endpoints of this part of the study are the occurrence of the following ADRs and their potential relation with genetic markers. The occurrence of the ADRs are defined as follows: - For excessive daytimes sleepiness: a score =5 on the daytime sleepiness (DS) section of the SCOPA-SLEEP; - Sleep disruption (SCOPA-SLEEP domain sleeping at night =7, wearables*(restlessness during sleep)) - For separate impulse control disorders (ICDs): scores =6 (gambling), =7 (eating, hobbyism/punding), =8 (buying, sex) on the related sections of the QUIP-RS; for the combined ICDs: a score =10 on the total score. - Presence of hallucinations: defined as a score = 1 on items 2-13 of the SAPS-PD. - Presence of dyskinesia’s: defined as a score =1 on item 4.1 of the MDS-UPDRS & wearables*. - Presence of motor fluctuations: defined as a score =1 on item 4.3 of the MDS-UPDRS & wearables*. - Presence of orthostatic hypotension: defined by a fall in systolic blood pressure of at least 20mm Hg or diastolic blood pressure of at least 10mm Hg when a person assumes a standing position. *The outcome features derived from the wearables are not yet available, as these will be developed by means of machine learning algorithms after completion of the entire dataset. Due to the nature of the machine learning algorithm, we cannot indicate which outcome features will be identified by the algorithm as most indicative of the presence of ADRs (i.e. dyskinesia’s, sleep disruption and motor fluctuations). Main clinical outcomes related to phenotypic characterization(disease severity and progression) as measured along two axis: I. Predominately non-dopaminergic symptoms: - Cognition - Global cognition: Montreal Cognitive Assessment - Visuospatal functioning (Pentagon drawing;) - Depression (Beck Depression Inventory-II) - Apathy (Apathy Evaluation Scale for Parkinson Disease (AES-12PD)) - Anxiety (Parkinson Anxiety S | — |
Secondary
| Measure | Time frame |
|---|---|
| Biobank containing comprehensive and uniformly acquired longitudinal clinical data and biological samples for identification and validation of biomarker panels and data-driven approaches to unravel heterogeneity in the Parkinson’s phenotype (i.e. rate of progression, cognitive and neuropsychiatric impairment and motor dysfunction), treatment response and occurrence of ADRs | — |
Contacts
Public ContactDaphne Geerse
LUMC
Outcome results
None listed