Status:
ACTIVE_NOT_RECRUITING
Parkinson's Disease Progression Study
Lead Sponsor:
Koneksa Health
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Regeneron Pharmaceuticals
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-85 years
Brief Summary
Disease Progression Study
Detailed Description
This is a longitudinal, observational Study to Determine Usability, Analytical and Clinical Validity and Biomarker Discovery for Wearable and Mobile Device Collected Objective Measurement of Disturbed...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Aged ≥18 years to ≤85 years of age.
- Body mass index (BMI) ≥18 to 40 kg/m2.
- In adequate health based on medical history and physical examination (other than PD) undertaken following standard care procedures and presenting minimal risk for taking part in the study, per investigator assessment.
- Participant or caregiver has demonstrated ability to perform satisfactory in-clinic and remote procedures during the screening period.
- Clinically established PD, consistent with Postuma et al (Mov Disord; 2015).
- H\&Y stage 1 or 2.
- Exclusion criteria:
- Unable to commit to 12 months of data collection.
- Planning to enroll in a clinical trial for disease modifying therapy that will overlap with the duration of this study.
- Parkinsonism due to drugs(s) and or toxin(s).
- Increased risk of falling, defined as \>6 falls within the 12 months prior to screening.
- Urine drug screen positive for opiates, phencyclidine (PCP), cocaine, or amphetamines.
- Regular binge drinking, defined as ≥4 alcoholic drinks for women or ≥5 alcoholic drinks for men, per investigator assessment.
- Current or recent (within 6 months prior to screening) diagnosis of a moderate or severe substance use disorder (excluding caffeine) according to Diagnostic and Statistical Manual of Mental Disorders-5 criteria. Note that nicotine use disorder is an exclusion criterion only if it has an effect on sleep (i.e., a participant who routinely awakens at night to smoke), and medical or recreational marijuana is not included in this exclusion criterion.
- Severe cardiopulmonary, hepatic, renal, or musculoskeletal disease such that activities of daily living are adversely impacted.
- History of neoplastic disease, with the exception of (1) an adequately treated basal cell carcinoma or carcinoma in situ of the cervix; (2) other malignancies which have been successfully treated \>5 years prior to screening without evidence of recurrence.
- Currently participating in another clinical trial, or previous participation in a clinical trial in which an investigational product was received within 30 days prior to screening or within at least 5 half-lives of the investigational product.
- Current or planned pregnancy.
- History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury (other than mild traumatic brain injury).
- Intracranial metallic or magnetic devices, such as a cochlear implant or deep brain stimulator.
- Implanted active device, such as a pacemaker or defibrillator.
- History of gene therapy, intracranial antisense oligonucleotide treatment, cell transplantation, or experimental brain surgery.
- Current untreated or unstable depressive disorder or a serious mood disorder requiring hospitalization.
- Other primary degenerative dementia or neurodegenerative conditions outside of the specific basket in which the participant is enrolled, where applicable.
- Other uncontrolled infectious, metabolic, or systemic diseases affecting the central nervous system, such as syphilis, hypothyroidism, vitamin B12 or folate deficiency, and other laboratory values.
- Any other medical, psychiatric, or social condition that, in the opinion of the investigator, is likely to unfavorably alter the risk-benefit of participation, to interfere with protocol compliance, or to confound safety or efficacy assessments.
- Additional exclusion criterion for the subset of treatment-naive participants only:
- 1\. No prior treatment to manage motor symptoms of PD; note that brief periods of dopaminergic therapy administered to establish diagnosis are not grounds for exclusion.
Exclusion
Key Trial Info
Start Date :
February 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06219629
Start Date
February 20 2024
End Date
February 1 2026
Last Update
September 9 2025
Active Locations (10)
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1
University of Colorado Health Neurosciences Center
Aurora, Colorado, United States, 80045
2
Parkinsons Disease And Movement Disorders Center Of Boca Raton
Boca Raton, Florida, United States, 33486
3
Accel Research Sites DeLand
DeLand, Florida, United States, 32720
4
Accel Research Sites St Petersburg-Largo
Largo, Florida, United States, 33777