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Not recruiting
Phase 2

Allopregnanolone

Sponsor:

University of Arizona

Code:

NCT04838301

Conditions

Alzheimer Dementia

Late Onset Alzheimer Disease

Neurodegenerative Diseases

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Allopregnanolone

Placebo

Study Details

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.

Conditions

Alzheimer Dementia

Late Onset Alzheimer Disease

Neurodegenerative Diseases

Study ID

NCT04838301

Start date

Aug 15, 2023

Status verified date

Jun, 2026

Completion date

Mar 18, 2027

Anticipated

Primary completion date

Nov 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Allo group

Allopregnanolone 4mg IV 30-minute infusion once per week for 6 months.

placebo comparator: Control group

Placebo (normal saline) IV 30-minute infusion once per week for 6 months.

Interventions

Allopregnanolone

Allopregnanolone 4mg IV via 30-minute infusion, once per week.

Placebo

Normal saline solution IV via 30-minute infusion, once per week

Primary outcome measure

  • Hippocampal volume [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

More Information

Sponsor

University of Arizona

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Mild Alzheimer Disease
  • Regenerative Therapeutic
  • Neurogenesis
  • Allopregnanolone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-06-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.