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NCT06344026

Phase 1/2a Study of ANPD001 in Parkinson Disease

Enrolling by Invitation
PHASE1Ages 40–75InterventionalTreatment
Aspen Neuroscience
~9 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:ANPD001Custom Device

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of treatment emergent adverse events (Safety and Tolerability)
Measured over 1 year (primary follow up)

Conditions

Parkinson Disease

Explore related trials

Parkinson Disease

Where it's being run

9 sites across 5 states
California5
Arizona1
Colorado1
Georgia1
New York1

Study leadership

  • Revati Shreeniwas, MD, FCCP · STUDY_CHAIR · Aspen Neuroscience

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Prior brain surgery that, in the opinion of the neurologist or neurosurgeon, contraindicates administration of ANPD001
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
Inability to temporarily stop anticoagulation or antiplatelet therapy for at least 2 weeks
History of malignancy (cerebral or systemic) within the prior 5 years, except treated cutaneous squamous or basal cell carcinomas
Contraindication to MRI / contrast CRT and/or use of contrast agents
Weight \> 300 lbs or Body Mass Index (BMI) \> 35
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
Pregnancy or lactation
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
Unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments
Any significant issue raised by the neurologist or neurosurgeon

What this trial measures

  • Incidence and severity of treatment emergent adverse events (Safety and Tolerability)1 year (primary follow up)

    incidence and severity of treatment emergent adverse events (TEAE) and serious adverse events (SAE)