Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Prescriptive Infusion Algorithm

    Procedure/Surgery

    The study intervention is comprised of the neurosurgical procedure and the bilateral intraputaminal delivery of AB-1005.

  • AB-1005

    Drug

    bilateral intraputaminal delivery of AB-1005

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Stage 1Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Investigate the use of PIA-based infusion for consistent intraputaminal administration of AB-1005 via CED under iMRI monitoring

Time frame
immediately after the intervention/procedure/surgery

Secondary outcomes

1

Duration of surgical procedure

Reduce the time the surgical procedure is performed

Time frame
through study completion, an average of 1 year
2

Change in total volumetric putaminal coverage within approximately 60-120 min from end of infusion

Time frame
immediately after the intervention/procedure/surgery
3

Accuracy of cannula tip placement at targeted first and last infusion stops in putamen

Time frame
immediately after the intervention/procedure/surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AskBio Inc

Lead sponsor

Bayer

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: