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Allopregnanolone for Mild Alzheimer's Disease

This study is testing a drug called Allopregnanolone to see if it can help people with mild Alzheimer's disease. Researchers want to find out if it is safe and if it can help restore brain structure and improve thinking abilities. You might be able to join if you are between 55 and 80 years old, have been diagnosed with probable Alzheimer's disease, and have a specific biomarker (p-Tau217) in your blood. The main goal is to see if Allopregnanolone can increase the size of a part of the brain called the hippocampus (which is important for memory) over six months. The study is currently recruiting about 100 participants.

Study design
This is a Phase 2, double-blind, randomized study where participants will receive either Allopregnanolone or a placebo (inactive substance). About 100 participants will be involved.
What's involved
You would receive weekly 30-minute intravenous (IV) infusions for 6 months, with brain imaging at the start, 3 months, and 6 months. After 6 months, all participants will receive Allopregnanolone for an additional 3 months.
Compensation
Not stated in the trial record.
Follow-up
Brain imaging to evaluate the primary endpoint will be conducted at baseline, 3 and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04838301

Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

Active, Not Recruiting
PHASE2Ages 55–80InterventionalTreatment
University of Arizona
~100 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:AllopregnanolonePlacebo

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hippocampal volume
Measured over Baseline to 6 months

Conditions

Alzheimer Dementia
Late Onset Alzheimer Disease
Neurodegenerative Diseases

Where it's being run

9 sites across 4 states
Florida4
Arizona2
California2
Massachusetts1

Study leadership

  • Roberta D Brinton, PhD · PRINCIPAL_INVESTIGATOR · University of Arizona
  • Lon Schneider, MD · PRINCIPAL_INVESTIGATOR · University of Southern California
  • Gerson D Hernandez, MD, MPH · STUDY_DIRECTOR · University of Arizona

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Hippocampal volumeBaseline to 6 months

    mm3