NCT04838301 · Phase 2 · RECRUITING
Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
This trial is testing allopregnanolone — a naturally occurring brain steroid — to see whether it slows or improves cognition in people with mild Alzheimer's dementia. It is a Phase 2 trial, meaning researchers are evaluating whether it works and is safe in a controlled setting. It is not yet proven or approved. Participants receive weekly IV infusions of the drug or a placebo over several months.
Eligibility criteria
Main Inclusion Criteria: * Men and postmenopausal women * Age 55 to 80 years old * Meets NIA-AA criteria for probable AD dementia * MMSE of 20-26 * Plasma p-Tau217 positive * Geriatric Depression Scale short form (GDS-S) score of ≤ 6 * No medical contraindications to participation * Capacity to provide informed consent at screening Main Exclusion Criteria: * Dementia other than probable AD * Use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the GABA-A receptor complex * History of stroke with a modified Hachinski Ischemic Scale score >4 * History of seizure disorder, focal brain lesion, traumatic brain injury * History within the last 5 years of a primary or recurrent malignant disease * Unstable or clinically significant cardiovascular, kidney or liver disease * MRI indicative of any other significant abnormality, including but not limited to one or more significant ARIA-E or macro-hemorrhage findings, or multiple microhemorrhages (>8), or Fazekas score of 3; encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions * Any conditions that would contraindicate MRI studies. * No evidence of AD-like pattern of brain atrophy
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