Phase 1/2a Study of ANPD001 in Parkinson Disease

Korábbi kezelés

• Prior brain surgery that, in the opinion of the neurologist or neurosurgeon, contraindicates administration of ANPD001
• Inability to temporarily stop anticoagulation or antiplatelet therapy for at least 2 weeks
• Significant drug-induced dyskinesia (> 3 for any body part on the Abnormal Involuntary Movement Scale [AIMS])
• Male or female with reproductive capacity who is unwilling to use barrier contraception for 3 months post-administration of the investigational product

Más betegség

• History of intracranial therapy for PD, including deep brain stimulation (DBS), focused ultrasound (FUS), gene therapy or other biological therapy
• History of cognitive impairment or dementia
• History of clinically significant Dopa Dysregulation syndrome
• History of epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological disease (other than PD), or poorly controlled cardiovascular disease
• History of malignancy (cerebral or systemic) within the prior 5 years, except treated cutaneous squamous or basal cell carcinomas

Laborértékek

• Newly diagnosed diabetes (HbA1c > 7.0%), uncontrolled diabetes > 8.0% requiring frequent medication changes, or any other acute or chronic medical condition that would significantly increase the risks of a neurosurgical procedure

Egyéb

• Contraindication to MRI / contrast CRT and/or use of contrast agents
• Weight > 300 lbs or Body Mass Index (BMI) > 35
• Pregnancy or lactation
• Unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments
• Any significant issue raised by the neurologist or neurosurgeon

• Age 40-75 years of age at time of consent in the trial-ready cohort study ANPD001-01
• Met all eligibility requirements for inclusion in the trial-ready cohort in clinical study ANPD001-01
• Diagnosed with Parkinson Disease at least 4 years ago
• Unequivocal motor response to Levodopa