Parkinson's Disease Biomarker Program

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Ashley Gerald

Principal Investigator
Richard Dewey, M.D.

Official Title

Longitudinal, Single-center Prospective Study to Assess Progression of Clinical Features and Biologic Markers of Parkinson's Disease Subjects of Varying Levels of Disease Severity

Brief Overview

The primary objective of this study is to obtain detailed clinical information and biologic
specimens from subjects with PD toward the ultimate end of identifying a biomarker of PD.
Because of the inherent difficulties of using clinical outcome measures to assess disease
modification, the identification of biomarkers of PD is of paramount importance. The ideal
PD biomarker would be one that is easily assayed in a convenient biological sample, varies
proportionally with disease severity, is abnormal during the pre-symptomatic phase of the
illness, and is unaffected by drugs or other interventions used to treat PD. The existence
of a sensitive biomarker with these properties would enable much more effective disease
modifying research that would likely be able to take advantage of smaller and potentially
shorter trials.


Subjects will be asked to attend study visits every 6 months for up to 5 years of follow up.
Each visit will consist of patient outcomes questionnaires, neurological exams, computerized
assessments of gait and balance, a video recorded motor exam, and biological specimen
collection for biomarker discovery.

Participant Eligibility

Inclusion Criteria:

- A diagnosis of idiopathic PD meeting UK PD Society Brain Bank Criteria (Step 1, Step
2, and 2 items present from step 3).1

- Male or female age 30 years or older at time of PD diagnosis, Hoehn & Yahr (H&Y)
stage I-IV.

- Confirmation from I-123 Ioflupane SPECT (DatScanĀ®) of dopamine transporter deficit
for de-novo, untreated patients.

- Clinical evidence of response to dopaminergic medication (MAO-B inhibitors, dopamine
agonists, levodopa, or combinations) in patients on treatment for PD.

- Ability to provide written informed consent in accordance with Good Clinical Practice
(GCP), International Conference on Harmonization (ICH), and local regulations.

- Able to make visits to UT Southwestern every 6 months for up to 5 years without undue

Exclusion Criteria:

- Idiopathic PD, H&Y stage 5, as these will be unable to participate in gait

- Confirmed or suspected atypical parkinsonian syndromes due to drugs, metabolic
disorders, encephalitis, or degenerative diseases.

- Presence of definite dementia (MoCA < 17)2.

- For de-novo subjects: received any of the following drugs that might interfere with
dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa,
methylphenidate, reserpine, or amphetamine derivative, within 6 months of screening.

- For the prospective CSF cohort: current treatment with anticoagulants (e.g.,
coumadin, heparin) that might preclude safe completion of the lumbar puncture.

- For the prospective CSF cohort: any condition that precludes the safe performance of
routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding
diathesis, or known clinically significant coagulopathy or thrombocytopenia.

- Any other medical or psychiatric condition or lab abnormality, which in the opinion
of the investigator might preclude participation.