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BlueRock PD

A Multi-center, Noninterventional Study Evaluating Variability, Reliability, and Compliance for the Parkinson's Disease Diary

All genders
person-wave 39-70
Recruiting now
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Principal Investigator: Bryan Ho, MD

This is a global, multi-center, noninterventional study that will collect data on patients with PD under standard-of-care treatment according to local routine clinical practice. The primary objective of the study is to assess the impact of the frequency of assessments on the variability over time, reliability, and compliance for the PD diary in patients with PD in whom medications do not provide adequate control of symptoms. The secondary objectives of the study are to document changes in motor function as a measure of disease progression and characterize the stability or rates of change on motor function, quality of life, and use of standard PD medications in patients with PD in whom medications do not provide adequate control of symptoms.

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Study details

Inclusion Criteria
  • 39 to ≤70 years of age at signing of informed consent.
  • Diagnosis of clinically established PD as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD.
  • Marked levodopa responsiveness at screening per investigator’s judgment (eg, an estimated ≥30% improvement of MDS-UPDRS Part III score in the off-medication versus on-medication state).
Exclusion Criteria
  • PD with risk of recurrent falls or only tremor-based symptoms.
  • Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD such as Alzheimer's disease.
  • Any available evidence inconsistent with dopamine deficiency (eg, 18F-DOPA positron emission tomography [PET] or dopamine transporter single-photon emission computed tomography [DAT-SPECT] imaging if performed).
Study Requirements

Participants will be assigned (1:1) to complete the PD diary either on 3 consecutive days in 1 week (Group A) or 2 consecutive days in each of 2 consecutive weeks (Group B) for a given study visit. During the study, data are collected on motor function, quality of life, and use of PD medications at Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24. The study duration by participants in this study will be up to approximately 24 months.

This is a noninterventional study; no investigational therapy (treatment) will be administered. No additional diagnostic or monitoring procedures will be applied to the participants outside of routine clinical practice. Participants will continue standard-of-care treatment per their physician.

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