Parkinsons Disease biomarkers program

Study ID
STU 082012-037

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Julia Koch
214-648-5343
julia.koch@utsouthwestern.edu

Principal Investigator
Richard Dewey

Summary

This study involves the development of two longitudinal prospective cohorts of PD patients at varying levels of severity who will undergo clinical assessment and biomarker sample collection at baseline and every 6 months for a minimum of three years. Further, a single longitudinal prospective cohort of control subjects will undergo collection of demographic data and gait analysis at baseline and every 6 months for a minimum of three years. The cohorts targeted for enrollment are: (1) de-novo, previously untreated patients within 5 years of symptom onset, n[?]20, (2) patients on treatment with and clinically responsive to Mao-B inhibitors, dopamine agonists, amantadine, or levodopa (or combinations), n[?]220, and (3) control subjects for gait analysis, n[?]240. Potential subjects may have cognitive impairment but must score above 17 on the MoCa (a diagnostic cut-off for dementia).2 establishment of these three cohorts will provide samples highly relevant to biomarker research. The de-novo population will allow search for biomarkers present early in the disease which can be studied apart from contamination by dopaminergic drugs, and the treated population, given our targeted numbers, should provide biosamples from a wide spectrum of PD severity; it will be possible to correlate putative biomarkers with disease severity. The control subjects will provide data on change of gait parameters over time with aging which will be important for interpreting any change in gait parameters seen in PD subjects.

Participant Eligibility

4.2.1. Inclusion Criteria for PD Population
1. A diagnosis of idiopathic PD meeting UK PD Society Brain Bank Criteria (Step 1, Step 2, and 2 items present from step 3).1
2. Male or female age 30 years or older at time of PD diagnosis, Hoehn & Yahr (H&Y) stage I-IV.
3. For de-novo subjects:
a) Confirmation from I-123 Ioflupane SPECT (DatScan(RegisteredTM)) of dopamine transporter.Clinical evidence of response to dopaminergic medication (MAO-B inhibitors, dopamine agonists, levodopa, or combinations) in patients on treatment for PD.
b) Lifetime exposure to dopaminergic agents of less than 90 days
c) Absence of dopaminergic therapy for at least 30 days before baseline visit
d) Not expected to require dopaminergic therapy for 30 days after baseline visit.
4. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
5. Able to make visits to UT Southwestern every 6 months for up to 5 years without undue hardship.

4.2.2. Inclusion criteria for control populations:
1. Male or Female aged 21 years or older at screening
2. Able to make visits to UT Southwestern every 6 months for up to 5 years without undue hardship.
3. May be spouse, significant other, family member, friend, or caregiver of a subject enrolled in the study with PD who plans to accompany the PD subject to visits.
4. May be a faculty or staff member of UT Southwestern who would like to function as a control subject.
5. May be any other person who has volunteered to function as a control subject and can reasonably be expected to complete 5 years of the required assessments.