Prescriptive Infusion Algorithm (PIA)
ConditionPARKINSON DISEASE (Disorder)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-75
SponsorAskBio Inc
About this trial
This study is being done to test a new way of delivering AB-1005 into the brain. The goal is to make the procedure easier and quicker to perform, while providing similar amounts of drug to the part of the brain that needs treatment.
Technical (Stage 0) To test if the new delivery method (prefrontal surgical approach) can consistently deliver AB-1005 to the putamen using MRI monitoring.
Technical (Stage 1) To test if the new delivery method (PIA-based infusion) can consistently deliver AB-1005 to the putamen using brain imaging by MRI.
Technical (Stage 2) To confirm the new delivery method works without brain imaging by MRI, using standard operating room tools including brain imaging by CT.
Safety (Stage 1 and 2) To assess the safety and tolerability of the new delivery method for AB-1005 up to 6 months after surgery
Eligibility criteria
Qualifiers
Participant must be 45 to 75 years of age inclusive, at the time of signing the informed consent.
>10 years since diagnosis of PD (at time of consenting / Screening Visit 1)
Rigidity
Resting tremor
Disqualifiers
Evidence of secondary or atypical parkinsonism (as determined by the neurologist)
Presence or history of psychosis or impulse control disorder (as determined by the neurologist)
Presence or history (within 2 years prior to screening) of substance use disorder (including alcohol) as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria (or in the judgment of the neurologist)
Presence of untreated or sub optimally treated depression (Beck Depression Inventory [BDI]-II score ≥20)
Trial design
Treatments tested in this trial
- Prescriptive Infusion Algorithm
- AB-1005
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
AskBio Inc
Lead sponsor
Bayer
Collaborator
Source ClinicalTrials.gov