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Clinical Trials/NL-OMON21445
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

Sponsor
Amsterdam UMC, location VUmc

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