Active — Not RecruitingNot Applicable

Parkinson's Disease Progression Study

United States82 participantsStarted 2024-02-20

Plain-language summary

Disease Progression Study

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Compliance; toolkit assessments

Timeframe: Baseline Day 1 through Day 365 End of Participation

NCT IDNCT06219629

SponsorKoneksa Health

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.