NCT04838301 Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
| NCT ID | NCT04838301 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Arizona |
| Condition | Alzheimer Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2026-11-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2023-08-15 with a primary completion date of 2026-11-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A phase 2, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of Allopregnanolone as a regenerative therapeutic for Alzheimer's disease.
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
Contact & Investigator
Roberta D Brinton, PhD
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT04838301 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 80 Years, studying Alzheimer Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04838301 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04838301 currently recruiting?
Yes, NCT04838301 is actively recruiting participants. Contact the research team at claudiml@arizona.edu for enrollment information.
Where is the NCT04838301 trial being conducted?
This trial is being conducted at Scottsdale, United States, Tucson, United States, Costa Mesa, United States, Los Alamitos, United States and 6 additional locations.
Who is sponsoring the NCT04838301 clinical trial?
NCT04838301 is sponsored by University of Arizona. The principal investigator is Roberta D Brinton, PhD at University of Arizona. The trial plans to enroll 100 participants.
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