Allopregnanolone for Parkinson's Disease

(Allo-PD Trial)

Overseen By Claudia M Lopez, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Roberta Brinton

Must be taking: Anti-Parkinson's

Must not be taking: Benzodiazepines, Anticonvulsants, Antipsychotics, others

Disqualifiers: Deep brain stimulation, Malignant disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this open-label, pilot clinical trial is to test allopregnanolone as a regenerative treatment in patients with Parkinson's disease (PD). The main questions this study aims to answer are: 1. Is a large-scale clinical trial testing how well it works in patients with PD feasible? 2. Is allopregnanolone safe and well-tolerated in patients with PD. 3. Can we see any signals of changes in imaging and clinical scales? Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and "Open-label" means the study is not blinded so both the participant and investigators know the assigned treatment.

Research Team

Scott Sherman, MD

Principal Investigator

University of Arizona

Roberta D Brinton, PhD

Principal Investigator

University of Arizona

Gerson D Hernandez, MD, MPH

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for individuals with Parkinson's Disease. Participants will receive weekly infusions of allopregnanolone over 12 weeks. There are specific inclusion and exclusion criteria, but they're not listed here.

Inclusion Criteria

I have been diagnosed with Parkinson's disease without a known cause.

Provision of signed and dated informed consent form

My Parkinson's medication doses have been stable for the last 30 days.

Exclusion Criteria

I have had DBS surgery for Parkinson's disease.

Iodine allergy, known serious hypersensitivity to ioflupane I-123, or other inability to undergo DaTscan

Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly infusions of allopregnanolone for 12 weeks

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Allopregnanolone

Trial Overview The study tests allopregnanolone as a potential regenerative treatment for Parkinson's Disease. It aims to determine the feasibility of a larger trial, assess safety and tolerability, and look for any positive changes in brain imaging and clinical assessments.

Participant Groups

Group I: Allo APOE4 carriers Experimental Treatment 1 Intervention

Group of 5 participants who are carriers of the APOE4 gene and will receive allopregnanolone 4mg administered weekly via a 30-min IV infusion for a duration of 12 weeks.

Group II: Allo APOE4 none-carriers Active Control 1 Intervention

Group of 5 participants who are none-carriers of the APOE4 gene and will receive allopregnanolone 4mg administered weekly via a 30-min IV infusion for a duration of 12 weeks.

Allopregnanolone is already approved in United States for the following indications:

Approved in United States as Zulresso for:

• Postpartum depression

Who Is Running the Clinical Trial?

Roberta Brinton

Lead Sponsor

Trials

2

Recruited

110+