Not Yet RecruitingPhase 2

Prescriptive Infusion Algorithm (PIA)

12 participantsStarted 2026-05-01

Plain-language summary

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 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

Who can participate

Age range45 Years – 75 Years

SexALL

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

Inclusion Criteria: * 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) * Presence of bradykinesia plus any of the following: * Rigidity * Resting tremor * Postural instability * Modified Hoehn and Yahr stage III-IV in the practically defined OFF state * Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score \>40 in the practically defined OFF state * Stable anti-PD medication regimen for at least 4 weeks prior to Screening Visit 1 and through Baseline Visit * ≥30% reduction in MDS-UPDRS Part III following a levodopa challenge * Must agree to use barrier method protection when engaging in intercourse/sexual activity with another person for at least 3 months post-dosing. * Male participants must refrain from donating sperm for at least 3 months post-dosing. * Female participants cannot be pregnant or breastfeeding at the time of screening. A woman of childbearing potential (WOCBP) must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at the required assessments * Provision of signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * Provision of signed consent to also participate in LTFU study ASK-PD0-CS002 Exclusion Criteria: * Evidence of secondary or atypical parkin…

What they're measuring

Amount of the putamen covered by the drug at the end of infusion, assessed by MRI

Timeframe: immediately after the intervention/procedure/surgery

Trial details

NCT IDNCT07215403

SponsorAskBio Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-30