Parkinson's Disease Progression Study

NCT06219629 | Active Not Recruiting

• 1 other identifier: KH007
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 10

Brief Summary

Disease Progression Study

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Compliance; toolkit assessments

  Percentage of total toolkit tasks completed during the remote data collection period

  Baseline Day 1 through Day 365 End of Participation

Secondary Outcomes (1)

• Usability; mobile application

  Baseline Day 1 through Day 365 End of Participation

Other Outcomes (34)

• Compliance; by category

  Baseline Day 1 through Day 365 End of Participation

• Compliance; by assessment

  Baseline Day 1 through Day 365 End of Participation

• Compliance; wrist-worn device

  Baseline Day 1 through Day 365 End of Participation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Parkinson's disease

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Koneksa Health: lead
• Merck Sharp & Dohme LLC: collaborator
• Regeneron Pharmaceuticals: collaborator

Study Sites (10)

University of Colorado Health Neurosciences Center

Aurora, Colorado, 80045, United States

Location

Parkinsons Disease And Movement Disorders Center Of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Accel Research Sites DeLand

DeLand, Florida, 32720, United States

Location

Accel Research Sites St Petersburg-Largo

Largo, Florida, 33777, United States

Location

N1 Research LLC

Orlando, Florida, 32825, United States

Location

Augusta University Health Movement Disorder Clinic

Augusta, Georgia, 30912, United States

Location

University of Kansas Medical Center Parkinson's Disease and Movement Disorder Center

Kansas City, Kansas, 66160, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Cleveland Clinic

Las Vegas, Nevada, 89106, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin biopsies; serum; plasma.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 23, 2024
• Study Start: February 20, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon preliminary analysis (if applicable) and end of study.
• Access Criteria: Publications will be shared with Clinical Site Investigators and industry professionals.

Locations

US (10)