NL-OMON21445RecruitingNot Applicable
Profiling Parkinson’s disease
Amsterdam UMC, location VUmc0 sites1,515 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,515
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •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: <55 years, 55-65 years and >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.
- •- 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
- •A potential participant who meets ANY of the following criteria will be excluded from participation in this study:
- •- 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.
- •- 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.
Investigators
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