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Status:

COMPLETED

Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression

Lead Sponsor:

Ken Marek, MD

Collaborating Sponsors:

Institute for Neurodegenerative Disorders

Conditions:

Parkinson Disease

Eligibility:

All Genders

30+ years

Phase:

PHASE2

Brief Summary

This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD p...

Detailed Description

Amendment 14 - 26-Mar-2018 Revised to reflect the implementation of PPMI Wearables and Sensor Study Companion Protocol Amendment 13 - 20-Nov-2017 Extension of study duration until 2023 for all cohort...

Eligibility Criteria

Inclusion

  • Parkinson Disease (PD) Subjects:
  • A diagnosis of Parkinson disease for 2 years or less at Screening.
  • Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit, or if applicable a VMAT-2 PET scan consistent with vesicular monoamine transporter deficit.
  • Not expected to require PD medication with at least 6 months from Baseline.
  • Male or female age 30 years or older at time of PD diagnosis.
  • Healthy Control (HC) Subjects:
  • • Male or female age 30 years or older at Screening.

Exclusion

  • Parkinson Disease (PD) Subjects:
  • Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or other PD medication.
  • Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline.
  • Has taken levodopa or dopamine agonists prior to Baseline for more than a total of 60 days.
  • Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
  • Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  • If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ or amphetamine type medications.
  • Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Use of investigational drugs within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
  • Healthy Control (HC) Subjects:
  • Current or active neurological disorder.
  • First degree relative with idiopathic PD (parent, sibling, child).
  • MoCA score \< 26.
  • Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
  • If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ) or amphetamine type medications.
  • Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  • Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Use of other investigational drugs within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
  • SWEDD Subjects:
  • All PD criteria apply, as above, except a SWEDD subject must have confirmation from imaging core that screening dopamine transporter SPECT scan shows no evidence of dopamine transporter deficit or if applicable a VMAT-2 PET scan shows no evidence of vesicular monoamine transporter deficit.
  • Prodromal Subjects:
  • Inclusion Criteria (Prodromal Subjects) 4.2.7.1. Subjects must have at least one of the following characteristics:
  • Hyposmia:
  • Male or female age 60 years or older
  • Confirmation from olfactory core that olfaction as determined by UPSIT is at or below the 10th percentile by age and gender
  • REM Behavior Disorder (RBD):
  • Male or female age 60 years or older
  • Confirmation from sleep core that subject's Polysomnography (PSG) meets criteria for RBD
  • LRRK2:
  • Male or female age 60 years or older
  • Written confirmation or documentation from testing facility that the individual is LRRK2 mutation positive 4.2.7.2. Confirmation from imaging core that screening dopamine transporter SPECT scan is read as eligible (see below). About 80 subjects will have a range of DAT deficit similar to subjects with early PD (mild to moderate DAT deficit). About 20 subjects will be selected with no DAT deficit or minimal DAT deficit similar in age, gender, and risk profile to those with mild to moderate DAT deficit. 4.2.7.3. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. 4.2.7.4. Willing and able to comply with scheduled visits, required study procedures and laboratory tests. 4.2.7.5. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Includes a negative urine pregnancy test on day of screening scan prior to injection (DaTSCAN).
  • Exclusion Criteria (Prodromal Subjects)
  • Current or active clinically significant neurological disorder or psychiatric disorder (in the opinion of the Investigator).
  • GDS score greater than or equal to 10 (GDS score of 5 - 9 requires Investigator discretion to enter study).
  • STAI Form Y-1 greater than or equal to 54 requires Investigator discretion to enter study.
  • A clinical diagnosis of dementia63 as determined by the investigator (Appendix 1).
  • A clinical diagnosis of Parkinson disease at the Screening visit as determined by the Investigator.
  • 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.
  • Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  • Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
  • Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
  • Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
  • Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
  • Genetic Cohort: Parkinson Disease Subjects - Inclusion:
  • Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting remor or bradykinesia) or either asymmetric resting tremor or asymmetric bradykinesia.
  • A diagnosis of Parkinson Disease for 7 years or less at screening.
  • Hoehn and Yahr state \<4 at baseline
  • Male or female age 18 years or older
  • Willingness to undergo genetic testing and to be informed of genetic testing results.
  • Confirmation of mutation in LRRK2, GBA or SNCA
  • For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine or amphetamine derivative must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DatSCAN(TM) imaging.
  • Exclusion:
  • Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  • Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis or clinically significant coagulopathy or thrombocytopenia.
  • Genetic cohort - Unaffected Individuals
  • Inclusion:
  • Male or female age 45 years or older at baseline with LRRK2 or GBA mutation and/or first degree relative with a LRRK2 or GBA mutation or
  • Male or female age 30 years or older at baseline with a SNCA mutation and/or a first degree relative with a SNCA mutation.
  • Unaffected subjects at high risk of LRRK2, GBA or SNCA mutation due to first degree relative with a LRRK2, GBA or SNCA mutation may choose either to be informed of the results or remain unaware of the results.
  • Unaffected subjects from an ethnic or geographic group knkown to have relatively high risk of LRRK2, GBA or SNCA mutation such as people of Ashkenazi Jewish or Basques descent) and who have a family member (either alive or deceased) who has/had PD must be willing to be informed of their own testing results.
  • Willingness to undergo genetic testing
  • For subjects taking any of the following drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to DatSCAN imaging.
  • Exclusion:
  • A clinical diagnosis of PD
  • Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture.
  • Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis or clinically significant coagulopathy or thrombocytopenia.
  • Genetic Registry - Inclusion:
  • Individual with a LRRK2, GBA or SNCA mutation and/or a first degree relative with a LRRK2, GBA or SNCA mutation.
  • Male or female age 18 years or older
  • Willingness to undergo genetic testing, but may choose either to be informed of the results or remain unaware of the results.

Key Trial Info

Start Date :

June 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2020

Estimated Enrollment :

952 Patients enrolled

Trial Details

Trial ID

NCT01141023

Start Date

June 1 2010

End Date

June 30 2020

Last Update

November 14 2023

Active Locations (34)

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Page 1 of 9 (34 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

Banner Research Institute

Sun City, Arizona, United States, 85351

3

University of California San Diego

La Jolla, California, United States, 92093-0948

4

University of California, San Francisco

San Francisco, California, United States, 94115