Allopregnanolone Regenerative Therapeutic for Early Alzheimer’s Disease: IV to IM Bridging Study

– Provision of signed and dated informed consent form

– Stated willingness to comply with all study procedures and availability for the
duration of the study

– Men or postmenopausal women, aged 55 years or older

– Diagnosis of MCI due to AD or mild AD

– In good general health as evidenced by medical history and with no medical
contraindications to participation

– MMSE > 20 at screen

– Caregiver willing and capable to accompany the patient to clinic visits

Exclusion Criteria:

– Daily use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and
other drugs that might interact with the GABA-A receptor complex.

– Seizure disorder, history of stroke, focal brain lesion, traumatic brain injury,
substance abuse, malignancy.

– Clinically significant laboratory or ECG abnormality obtained at screening visit.

– MRI indicative of significant abnormality, including but not limited to evidence of a
single prior hemorrhage or infarct >1 cm3, multiple lacunar infarcts (>1) or evidence
of a single prior infarct >1cm3, evidence of a cerebral contusion, encephalomalacia,
aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (e.g.
abscess or tumor).

– Has any contraindications for MRI studies, including claustrophobia, the presence of
metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with
MRI.

– Is currently enrolled in a clinical trial involving an off-label use of an
investigational drug or device, or concurrently enrolled in any other type of medical
research or observational study judged not to be scientifically or medically
compatible with this study.