Parkinson's Disease Progression Study

A Two Part, Observational Basket Study to Determine Usability, Validity and Biomarker Discovery for Mobile EEG, Wearable and Device Collected Objective Measurement of Disturbed Sleep and Neurologic Disorders (LEARNS)

Disease Progression Study

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease

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 Sleep and Neurologic Disorders. The Disease Progression Study part in Parkinson's Disease has a duration of approximately 12 months.

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Neurosciences Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinsons Disease And Movement Disorders Center Of Boca Raton
    • DeLand, Florida, United States, 32720
      • Accel Research Sites DeLand
    • Largo, Florida, United States, 33777
      • Accel Research Sites St Petersburg-Largo
    • Orlando, Florida, United States, 32825
      • N1 Research LLc
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Health Movement Disorder Clinic
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Parkinson's Disease and Movement Disorder Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Parkinson's disease

Description

Inclusion criteria:

1. Aged ≥18 years to ≤85 years of age.
2. Body mass index (BMI) ≥18 to 40 kg/m2.
3. 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.
4. Participant or caregiver has demonstrated ability to perform satisfactory in-clinic and remote procedures during the screening period.
5. Clinically established PD, consistent with Postuma et al (Mov Disord; 2015).
6. H&Y stage 1 or 2.

Exclusion criteria:

1. Unable to commit to 12 months of data collection.
2. Planning to enroll in a clinical trial for disease modifying therapy that will overlap with the duration of this study.
3. Parkinsonism due to drugs(s) and or toxin(s).
4. Increased risk of falling, defined as >6 falls within the 12 months prior to screening.
5. Urine drug screen positive for opiates, phencyclidine (PCP), cocaine, or amphetamines.
6. Regular binge drinking, defined as ≥4 alcoholic drinks for women or ≥5 alcoholic drinks for men, per investigator assessment.
7. 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.
8. Severe cardiopulmonary, hepatic, renal, or musculoskeletal disease such that activities of daily living are adversely impacted.
9. 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.
10. 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.
11. Current or planned pregnancy.
12. History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury (other than mild traumatic brain injury).
13. Intracranial metallic or magnetic devices, such as a cochlear implant or deep brain stimulator.
14. Implanted active device, such as a pacemaker or defibrillator.
15. History of gene therapy, intracranial antisense oligonucleotide treatment, cell transplantation, or experimental brain surgery.
16. Current untreated or unstable depressive disorder or a serious mood disorder requiring hospitalization.
17. Other primary degenerative dementia or neurodegenerative conditions outside of the specific basket in which the participant is enrolled, where applicable.
18. 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.
19. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability; mobile application	Percentage of participants reporting a mobile application System Usability Scale (SUS) score ≥68	Baseline Day 1 through Day 365 End of Participation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance; by category	Percentage of toolkit assessments completed, by category (motor, speech, and cognitive)	Baseline Day 1 through Day 365 End of Participation
Compliance; by assessment	Percentage of toolkit assessments completed, by individual assessment	Baseline Day 1 through Day 365 End of Participation
Compliance; wrist-worn device	Compliance with the wrist-worn device in hours/day	Baseline Day 1 through Day 365 End of Participation
Usability; study phone	Usability of the study phone, evaluated with the usability questionnaire	Baseline Day 1 through Day 365 End of Participation
Usability; study tablet	Usability of the study tablet, evaluated with the usability questionnaire	Baseline Day 1 through Day 365 End of Participation
Usability; wrist-worn device	Usability of the wrist-worn device, evaluated with the usability questionnaire	Baseline Day 1 through Day 365 End of Participation
Usability; software platform	Usability of the SaaS platform, evaluated with the usability questionnaire	Baseline Day 1 through Day 365 End of Participation
Usable data; toolkit assessments	Percentage of total toolkit assessments that generate usable data	Baseline Day 1 through Day 365 End of Participation
Usable data; by category	Percentage of toolkit assessments that generate usable data, by category (motor, speech, and cognitive)	Baseline Day 1 through Day 365 End of Participation
Usable data; by assessment	Percentage of toolkit assessments that generate usable data, by individual assessment	Baseline Day 1 through Day 365 End of Participation
Usable data; wrist-worn device	Amount of usable data obtained from the wrist-worn device	Baseline Day 1 through Day 365 End of Participation
Content validity; by assessment	Content validity evaluated with the in-house content validity survey, by toolkit assessment	Baseline Day 1 through Day 365 End of Participation
Content validity; by PRO	Content validity evaluated with the in-house content validity survey, by PRO	Baseline Day 1 through Day 365 End of Participation
Criterion validity; toolkit assessments	Criterion validity evaluated by examining associations between measures derived from the toolkit assessments and disease-specific gold-standard assessments	Baseline Day 1 through Day 365 End of Participation
Criterion validity; wrist-worn device	Criterion validity evaluated by examining associations between measures derived from the wrist-worn device and disease-specific gold-standard assessments	Baseline Day 1 through Day 365 End of Participation
Construct validity; by data capture location	Evaluation of the differences between measures obtained remotely versus in-clinic	Baseline Day 1 through Day 365 End of Participation
Construct validity; by data capture frequency	Evaluation of the differences between measures obtained at different frequencies, such as daily vs weekly	Baseline Day 1 through Day 365 End of Participation
Convergent validity; motor assessments	Convergent validity evaluated by examining associations between measures derived from the motor assessments	Baseline Day 1 through Day 365 End of Participation
Convergent validity; cognitive assessments	Convergent validity evaluated by examining associations between measures derived from the cognitive assessments	Baseline Day 1 through Day 365 End of Participation
Convergent validity; speech assessments	Convergent validity evaluated by examining associations between measures derived from the speech assessments	Baseline Day 1 through Day 365 End of Participation
Discriminant validity; toolkit assessments	Discriminant validity evaluated by examining associations between measures derived from toolkit assessments identified between categories (motor vs cognitive vs speech)	Baseline Day 1 through Day 365 End of Participation
Evaluation of change; toolkit assessments	Evaluation of change over time in measures derived from the toolkit assessments	Baseline Day 1 through Day 365 End of Participation
Evaluation of change; wrist-worn device	Evaluation of change over time in measures derived from the wrist-worn device	Baseline Day 1 through Day 365 End of Participation
Detection of disease progression; toolkit assessments	Evaluation of change over time in measures derived from the toolkit assessments, comparing progressors and non-progressors as defined by the PGI-C	Baseline Day 1 through Day 365 End of Participation
Detection of disease progression; wrist-worn device	Evaluation of change over time in measures derived from the wrist-worn device, comparing progressors and non-progressors as defined by the PGI-C	Baseline Day 1 through Day 365 End of Participation
Test-retest reliability; toolkit assessments	Test-retest reliability evaluated by examining associations between measures derived from the toolkit assessment device captured at adjacent timepoint	Baseline Day 1 through Day 365 End of Participation
Internal consistency reliability; Cronbach's alpha	Internal consistency reliability evaluated by examining Cronbach's alpha (for composite scores only, as applicable)	Baseline Day 1 through Day 365 End of Participation
Internal consistency reliability; item-total associations	Internal consistency reliability evaluated by examining item-total associations (for composite scores only, as applicable	Baseline Day 1 through Day 365 End of Participation
Internal consistency reliability; directionality of change	Internal consistency reliability evaluated by comparing the directionality of change in individual components (for composite scores only, as applicable)	Baseline Day 1 through Day 365 End of Participation
Minimum valid dataset	Determination of the minimum valid dataset required to monitor disease progression	Baseline Day 1 through Day 365 End of Participation
Comparison of digital and non-digital biomarkers/assessments; toolkit assessments	Evaluation of the associations between measures derived from the toolkit assessments and non-digital biomarkers	Baseline Day 1 through Day 365 End of Participation
Comparison of digital and non-digital biomarkers/assessments; wrist-worn device	Evaluation of the associations between measures derived from the wrist-device and non-digital biomarkers	Baseline Day 1 through Day 365 End of Participation
Subgroup analyses	To evaluate the extent to which compliance, usability, usable data, validity, and reliability differ by subgroup/s	Baseline Day 1 through Day 365 End of Participation
Evaluation of composite scores	Evaluation of the concepts listed above for composite scores, if applicable	Baseline Day 1 through Day 365 End of Participation

Collaborators and Investigators

• Sponsor: Koneksa Health
• Collaborators: Merck Sharp & Dohme LLC; Regeneron Pharmaceuticals
• Investigators: Study Director: Jessie P Bakker, PhD, Koneksa Health

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: KH007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie results in a publication
• IPD Sharing Time Frame: Upon preliminary analysis (if applicable) and end of study.
• IPD Sharing Access Criteria: Publications will be shared with Clinical Site Investigators and industry professionals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No