Parkinson's Disease Progression Study

Korábbi kezelés

• 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.
• 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.
• 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.
• Intracranial metallic or magnetic devices, such as a cochlear implant or deep brain stimulator.
• 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.

Más betegség

• Planning to enroll in a clinical trial for disease modifying therapy that will overlap with the duration of this study.
• Severe cardiopulmonary, hepatic, renal, or musculoskeletal disease such that activities of daily living are adversely impacted.
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury (other than mild traumatic brain injury).
• 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.
• Other primary degenerative dementia or neurodegenerative conditions outside of the specific basket in which the participant is enrolled, where applicable.
• 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:

Laborértékek

• 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.

Egyéb

• Unable to commit to 12 months of data collection.
• Regular binge drinking, defined as ≥4 alcoholic drinks for women or ≥5 alcoholic drinks for men, per investigator assessment.
• Current or planned pregnancy.
• Implanted active device, such as a pacemaker or defibrillator.

• 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.