Parkinson's DiseasePDBPNCT01767818
Parkinson's Disease Biomarker Program
An observational study of Parkinson's Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
To determine the predictive value of iTUG/iSWAY test results on future course of the disease
This analysis aims to determine if automated gait or balance parameters can classify PD subjects as fast vs slow progressors, and whether gait or balance parameters can track disease progression
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startNov 2012
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Richard Dewey, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767818
- Sponsor's protocol ID
- NS-12-011
- Other IDs
- 1U01NS082148-01
- Acronym
- PDBP
- Status last verified
- May 2018
- First submitted
- 7 Jan 2013
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33538517
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01767818
- Acronym / sponsor ID
- PDBP / NS-12-011
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Nov 2012
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 5 years
This analysis will evaluate rates of progression in PD subjects and determine predictors of fast vs. slow progression
1 secondary outcome
To determine the predictive value of iTUG/iSWAY test results on future course of the disease
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Derived from this study: PubMed 33538517Sethi 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.
- Parkinson's Disease Biomarker Program Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Dewey, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.