The purpose of this study is to determine if hydroxychloroquine is safe to take and whether there is potential for it to slow the progression of PD symptoms. This will be done by comparing how PD symptoms progress throughout the study compared to how people with PD typically progress. Within PD, it is thought that an inflammation response is associated with abnormal forms of a protein called alpha-synuclein in the brain. Individuals who have taken this medication for other conditions have been shown to be less likely to develop PD than people who have not taken this medication. Therefore, it is hoped that the study drug may interrupt the inflammation response and in turn stop/delay the progression of PD.
The subject is ≥35 and ≤80 years of age at the time of informed consent.
The subject has a clinical diagnosis of PD for at least 6 months and for no longer than 4 years before initiation of screening as confirmed by a neurologist using the MDS Criteria for Parkinson's Disease (Postuma, Berg et al. 2015)
The subject has a Hoehn and Yahr score ≤2.
The subject has been on stable doses of PD medications for at least 30 days and the investigator does not anticipate they will require a change of their usual PD medications for a period of 48 weeks.
The subject has atypical or secondary parkinsonism by medical history or in the opinion of the investigator. Atypical parkinsonism includes, but is not limited to, diagnoses of progressive supranuclear palsy, cortico-basal syndrome, and multiple system atrophy. Secondary parkinsonism includes drug-induced, toxin-induced, postinfectious, posttraumatic, or vascular parkinsonism.
The subject has a history of (within 60 days before initiation of screening) or has planned upcoming major surgery that could interfere with, or for which the treatment might interfere with, the conduct of the study or that would pose an unacceptable risk to the subject in the opinion of the investigator.
The subject has any active or chronic disease including but not limited to cardiomyopathy or condition other than PD that could interfere with, or for which the treatment might interfere with, the conduct of the study or pose an unacceptable risk to the subject in the opinion of the investigator based on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests.
Minor deviations of laboratory values from the normal range may be acceptable if judged by the investigator to have no/minor clinical relevance.
Single group
Hydroxychloroquine (HCQ)
DrugThe intervention involves hydroxychloroquine (HCQ), administered orally in 200 mg tablets, with a dosing schedule of 200 mg twice daily (400 mg per day). The treatment duration is 48 weeks, after which participants will enter a 4-week safety follow-up period. HCQ will be taken alongside stable doses of Parkinson's disease (PD) medications, with no anticipated changes during the study. Monitoring for adverse events, laboratory assessments, and efficacy evaluations will occur regularly throughout the 12-month period. The study does not include a placebo group or other treatment arms.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
All participants exposed to HCQ at least once will be assessed for: * Incidence and severity of treatment-emergent adverse events (TEAEs) * Relationship of TEAEs to HCQ * Percentage of discontinuations due to adverse events (AEs)
Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical Motor Progression Using MDS-UPDRS Part III
Another primary clinical outcome is assess change in motor symptom severity, specifically using the movement disorder society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. A ≥4-point increase (one standard deviation) over 48 weeks will be used as a threshold to assess whether HCQ delays clinical motor progression of PD when compared to historical controls.
Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical PD Progression Using CGI-C Scale
The Clinical Global Impression of Change (CGI-C) scale assesses the clinician's perception of the change in a patient's condition. It ranges from 1 (very much improved) to 7 (very much worse). A score of 1-3 indicates improvement, while a score of 5-7 indicates worsening of the condition. This study will identify the number of participants with worsening CGI-C scale by the end of the study.
Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical PD Progression Using CGI-S Scale
The Clinical Global Impression-Severity (CGI-S) scale will be used to assess the severity of Parkinson's disease symptoms based on clinician judgment. The scale ranges from 1 (normal, not at all ill) to 7 (extremely ill). A higher score indicates more severe symptoms. A reduction in score will indicate an improvement in disease severity. This study will identify the number of participants with worsening CGI-S scale by the end of the study.
Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical PD Progression Using PGI-S Scale
The Patient Global Impression-Severity (PGI-S) scale measures the patient's assessment of the severity of their Parkinson's disease symptoms at the time of the assessment. The scale ranges from 1 (not at all ill) to 7 (extremely ill). A higher score indicates greater severity, and a decrease in score over time indicates improvement. This study will identify the number of participants with worsening PGI-S scale by the end of the study.
Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical PD Progression Using PGI-C Scale
The Patient Global Impression of Change (PGI-C) measures the patient's own perception of how much their condition has changed since the beginning of the study. The scale ranges from 1 (very much improved) to 7 (very much worse), with 1-3 indicating improvement and 5-7 indicating worsening. This study will identify the number of participants with worsening PGI-C scale by the end of the study.
Change in Motor Score as Assessed by the PRIMS Digital Assessment
Time from baseline to clinically meaningful progression on motor signs of the disease, as assessed by a \>= 4 point increase in the MDS-UPDRS part III score (one standard deviation) in comparison to historical controls.
Change in Motor Function as Assessed by Celestra Gait Assessment
* Adherence: Measured by analyzing the total number of tasks completed, divided by the total number of tasks prompted * Percent change from baseline of gait metrics/composite score generated from gait measures using Celestra insole sensors
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