Parkinson's Disease Progression Study

Parkinson Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219629
• Other study ID #: KH007
• Status: Recruiting
• Start date: February 20, 2024
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: Koneksa Health
• Contact: Koneksa Health
• Phone: 551-866-0025
• Email: KH007[@]koneksahealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Disease Progression Study

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
United States	University of Colorado Health Neurosciences Center	Aurora	Colorado
United States	Parkinsons Disease And Movement Disorders Center Of Boca Raton	Boca Raton	Florida
United States	Accel Research Sites DeLand	DeLand	Florida
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Accel Research Sites St Petersburg-Largo	Largo	Florida
United States	N1 Research LLC	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Koneksa Health	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance; by category	Percentage of toolkit assessments completed, by category (motor, speech, and cognitive)	Baseline Day 1 through Day 365 End of Participation
Other	Compliance; by assessment	Percentage of toolkit assessments completed, by individual assessment	Baseline Day 1 through Day 365 End of Participation
Other	Compliance; wrist-worn device	Compliance with the wrist-worn device in hours/day	Baseline Day 1 through Day 365 End of Participation
Other	Usability; study phone	Usability of the study phone, evaluated with the usability questionnaire	Baseline Day 1 through Day 365 End of Participation
Other	Usability; study tablet	Usability of the study tablet, evaluated with the usability questionnaire	Baseline Day 1 through Day 365 End of Participation
Other	Usability; wrist-worn device	Usability of the wrist-worn device, evaluated with the usability questionnaire	Baseline Day 1 through Day 365 End of Participation
Other	Usability; software platform	Usability of the SaaS platform, evaluated with the usability questionnaire	Baseline Day 1 through Day 365 End of Participation
Other	Usable data; toolkit assessments	Percentage of total toolkit assessments that generate usable data	Baseline Day 1 through Day 365 End of Participation
Other	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
Other	Usable data; by assessment	Percentage of toolkit assessments that generate usable data, by individual assessment	Baseline Day 1 through Day 365 End of Participation
Other	Usable data; wrist-worn device	Amount of usable data obtained from the wrist-worn device	Baseline Day 1 through Day 365 End of Participation
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Minimum valid dataset	Determination of the minimum valid dataset required to monitor disease progression	Baseline Day 1 through Day 365 End of Participation
Other	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
Other	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
Other	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
Other	Evaluation of composite scores	Evaluation of the concepts listed above for composite scores, if applicable	Baseline Day 1 through Day 365 End of Participation
Primary	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	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