Parkinson's Disease Biomarker Program

NCT01767818 | Completed

• 2 other identifiers: NS-12-0111U01NS082148-01
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• To estimate the mean rates of change and the variability around the mean of clinical outcomes in PD patients over 3-5 years of follow-up comparing these rates between PD patients of each stage of the Hoehn and Yahr.

  This analysis will evaluate rates of progression in PD subjects and determine predictors of fast vs. slow progression

  5 years

Secondary Outcomes (1)

• To determine the predictive value of iTUG/iSWAY test results on future course of the disease

  5 years

Study Arms (3)

Previously treated PD patients

220 subjects with PD treated and responsive to dopaminergic medication

Previously untreated PD

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

Healthy age-matched controls

46 age-matched healthy controls will be studied.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(1) de-novo, previously untreated patients within 5 years of symptom onset, n=20, and (2) patients on treatment with and clinically responsive to MAO-B inhibitors, dopamine agonists, amantadine, or levodopa (or combinations), n=220 and (3) healthy control patients without evidence of degenerative nerological disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Sethi A, Dilwali S, McCreary M, Dewey RB Jr. Oral Levodopa Formulation Does Not Affect Progression of Parkinson Disease. Clin Neuropharmacol. 2021 Mar-Apr 01;44(2):47-52. doi: 10.1097/WNF.0000000000000437.

  PMID: 33538517 DERIVED

Related Links

• Parkinson's Disease Biomarker Program Official Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen collection from all enrolled patients and cerebrospinal fluid (CSF) from patients who have provided additional and optional consent to CSF collection.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Richard Dewey, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 14, 2013
• Study Start: November 1, 2012
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)