Parkinson's Disease Biomarker Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

238 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Previously treated PD patients

220 subjects with PD treated and responsive to dopaminergic medication

No interventions assigned to this group

Previously untreated PD

20 subjects with de-novo, previously untreated PD confirmed by I-123 Ioflupane SPECT

No interventions assigned to this group

Healthy age-matched controls

46 age-matched healthy controls will be studied.

No interventions assigned to this group

Eligibility Criteria

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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 (DatScan®) 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 hardship.

Exclusion Criteria

* Idiopathic PD, H\&Y stage 5, as these will be unable to participate in gait assessments.
* 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.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes