Allopregnanolone As a Regenerative Treatment for Parkinson's Disease

Inclusion Criteria:

• 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 toscreening

• Provision of signed and dated informed consent form

Exclusion Criteria:

• 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 otherinability to undergo DaTscan.

• Clinically significant abnormal laboratory value and/or clinically significantunstable medical or psychiatric illness.

• History within the last 5 years of a primary or recurrent malignant disease, withthe exception of resected cutaneous squamous cell carcinoma in situ, basal cellcarcinoma, cervical carcinoma in situ, or prostate cancer in situ with apost-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, inthe investigator's opinion, could interfere with the safety and efficacy analyses inthis study.

• History of chronic alcohol or substance abuse/dependence within the past 3 years.

• Current use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs thatmight interact with the gamma-aminobutyric acid-A (GABA-A) receptor complex; use ofcalcium-channel blockers (e.g., amlodipine); use of dietary supplements containingPregnenolone.

• Treatment with another investigational drug within 3 months of screening.