Last reviewed · How we verify
NCT04838301: REGEN-BRAIN©
Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease
Recruiting now
Phase 2
Last updated 13 March 2026
What this trial tests
Phase 2 trial testing Allopregnanolone in Alzheimer Dementia in 100 participants. Currently enrolling.
Timeline
15 August 2023
Primary endpoint
18 November 2026
18 November 2026
18 March 2027
Quick facts
| Lead sponsor | University of Arizona |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 15 August 2023 |
| Primary completion | 18 November 2026 |
| Estimated completion | 18 March 2027 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- Allopregnanolone — full drug profile →
- Placebo
Conditions studied
- Alzheimer Dementia — all drugs for Alzheimer Dementia →
- Late Onset Alzheimer Disease — all drugs for Late Onset Alzheimer Disease →
- Neurodegenerative Diseases — all drugs for Neurodegenerative Diseases →
Sponsor
University of Arizona
Who can join
Adults 55 to 80, any sex, with Alzheimer Dementia or Late Onset Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Alzheimer's disease drug development pipeline: 2022.
Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295 -
Alzheimer's disease drug development pipeline: 2023.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385 -
Alzheimer's disease drug development pipeline: 2024.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2024 · cited 209× · PMID 38659717 · DOI 10.1002/trc2.12465 -
Glutamate and GABA in Microglia-Neuron Cross-Talk in Alzheimer's Disease.
Czapski GA, Strosznajder JB. · · 2021 · cited 125× · PMID 34769106 · DOI 10.3390/ijms222111677 -
Alzheimer's Disease: Novel Targets and Investigational Drugs for Disease Modification.
Cummings JL, Osse AML, Kinney JW. · · 2023 · cited 75× · PMID 37728864 · DOI 10.1007/s40265-023-01938-w -
Antiageing strategy for neurodegenerative diseases: from mechanisms to clinical advances.
Jiang Q, Liu J, Huang S, Wang XY, et al · · 2025 · cited 74× · PMID 40059211 · DOI 10.1038/s41392-025-02145-7 -
Neuroactive Steroids, Toll-like Receptors, and Neuroimmune Regulation: Insights into Their Impact on Neuropsychiatric Disorders.
Balan I, Boero G, Chéry SL, McFarland MH, et al · · 2024 · cited 17× · PMID 38792602 · DOI 10.3390/life14050582 -
Allopregnanolone: Regenerative therapeutic to restore neurological health.
Hernandez GD, Brinton RD. · · 2022 · cited 17× · PMID 36532370 · DOI 10.1016/j.ynstr.2022.100502
Verify or expand the search:
- PubMed search for NCT04838301
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Allopregnanolone
Trials testing the same drug.
- NCT04003285 — Allopregnanolone in Chronic Complex Traumatic Brain Injury · Phase 2 · not yet recruiting
- NCT06263010 — Allopregnanolone as a Regenerative Treatment for Parkinson's Disease · Phase 1 · completed
- NCT03748303 — Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study · Phase 1 · terminated
- NCT04015869 — Effect of Allopregnanolone on Stress-induced Craving · Phase 1 · completed
Other recruiting trials for Alzheimer Dementia
Currently open trials in the same condition.
- NCT07140601 — Environmental Pollutants and Neurological Disorders · recruiting
- NCT07222280 — Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy · NA · recruiting
- NCT03926520 — Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD) · NA · recruiting
- NCT04289402 — Individualized Brain Stimulation to Improve Mobility in Alzheimer's Disease · NA · active not recruiting
- NCT04055376 — Daily Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease · NA · active not recruiting
Other University of Arizona trials
Trials by the same sponsor.
- NCT04062890 — Inhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin Resistance · Phase 2 · withdrawn
- NCT05569486 — Elucidating the Central Mechanisms of Action for Green Light Therapy in Managing Chronic Pain · NA · not yet recruiting
- NCT05064111 — Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy · suspended
- NCT06567899 — Mechanistic Underpinnings of Preeclampsia · not yet recruiting
- NCT07254793 — Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04838301 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arizona
- Last refreshed: 13 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04838301.
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