NCT06263010 · Phase 1 · COMPLETED
Allopregnanolone as a Regenerative Treatment for Parkinson's Disease
This trial is testing allopregnanolone, a naturally occurring brain steroid, as a possible regenerative treatment for Parkinson's disease. Participants receive weekly intravenous infusions for 12 weeks, with no placebo group. It is a Phase 1 pilot study — the primary goals are to check safety and tolerability, and to see whether a larger trial would even be practical. It is not yet testing whether the drug works.
You may qualify if
- History of Idiopathic sporadic Parkinson disease
- Hoehn \& Yahr stage 1-4
- Have been on stable doses of all anti-Parkinson's medications for 30 days prior to screening
- Provision of signed and dated informed consent form
You're excluded if
- Evidence of Parkinsonian syndrome.
- Any conditions that would contraindicate MRI studies.
- Undergone deep brain stimulation (DBS) surgery as treatment for PD.
- 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.
- History within the last 5 years of a primary or recurrent malignant disease, with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or prostate cancer in situ with a post-treatment prostatic-specific antigen within normal range.
- Serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than PD), psychiatric, immunologic, or hematologic disease, and any other conditions that, in the investigator's opinion, could interfere with the safety and efficacy analyses in this study.
- History of chronic alcohol or substance abuse/dependence within the past 3 years.
- Current use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the gamma-aminobutyric acid-A (GABA-A) receptor complex; use of calcium-channel blockers (e.g., amlodipine); use of dietary supplements containing Pregnenolone.
- Treatment with another investigational drug within 3 months of screening.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-13