Clinical trial NCT06219629: Parkinson's Disease Progression Study
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson Disease
Lead sponsor: Koneksa Health
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
name: Regeneron Pharmaceuticals
First posted: 2024-01-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Parkinson's disease

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

Eligibility criteria: 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.

Primary outcomes:
measure: Compliance; toolkit assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
Secondary outcomes:
measure: Usability; mobile application
timeFrame: Baseline Day 1 through Day 365 End of Participation
Other outcomes:
measure: Compliance; by category
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Compliance; by assessment
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Compliance; wrist-worn device
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Usability; study phone
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Usability; study tablet
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Usability; wrist-worn device
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Usability; software platform
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Usable data; toolkit assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Usable data; by category
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Usable data; by assessment
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Usable data; wrist-worn device
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Content validity; by assessment
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Content validity; by PRO
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Criterion validity; toolkit assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Criterion validity; wrist-worn device
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Construct validity; by data capture location
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Construct validity; by data capture frequency
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Convergent validity; motor assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Convergent validity; cognitive assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Convergent validity; speech assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Discriminant validity; toolkit assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Evaluation of change; toolkit assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Evaluation of change; wrist-worn device
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Detection of disease progression; toolkit assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Detection of disease progression; wrist-worn device
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Test-retest reliability; toolkit assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Internal consistency reliability; Cronbach's alpha
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Internal consistency reliability; item-total associations
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Internal consistency reliability; directionality of change
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Minimum valid dataset
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Comparison of digital and non-digital biomarkers/assessments; toolkit assessments
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Comparison of digital and non-digital biomarkers/assessments; wrist-worn device
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Subgroup analyses
timeFrame: Baseline Day 1 through Day 365 End of Participation
measure: Evaluation of composite scores
timeFrame: Baseline Day 1 through Day 365 End of Participation
Locations:
city: Aurora
country: United States
facility: University of Colorado Health Neurosciences Center
state: Colorado
city: Boca Raton
country: United States
facility: Parkinsons Disease And Movement Disorders Center Of Boca Raton
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites DeLand
state: Florida
city: Largo
country: United States
facility: Accel Research Sites St Petersburg-Largo
state: Florida
city: Orlando
country: United States
facility: N1 Research LLC
state: Florida
city: Augusta
country: United States
facility: Augusta University Health Movement Disorder Clinic
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center Parkinson's Disease and Movement Disorder Center
state: Kansas
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Las Vegas
country: United States
facility: Cleveland Clinic
state: Nevada
Study officials:
affiliation: Koneksa Health
name: Jessie P Bakker, PhD
role: STUDY_DIRECTOR
References: