NCT03748303

Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study

Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: IV to IM Bridging Study

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identifying the intramuscular dose equivalent to the 4mg intravenous dose and assess its safety and tolerability as a weekly injection.

Detailed description

The purpose of this bridging study is to advance the therapeutic development of Allopregnanolone (Allo) by using the intramuscular (IM) route of administration as an alternative to the intravenous (IV) route. In order to identify the equivalent IM dose we will conduct pharmacokinetic (PK) analysis previously informed by simulations and modeling. We will recruit a total of 12 participants, both males and females equally distributed, into this single-arm, open-label study. PK analysis and dose finding will take place for the initial 4 weeks; some participants may not require all 4 weeks of initial dosing to establish maintenance dose. Once maintenance dose is established all participants will receive weekly administration of Allo IM until they complete 12 weeks total of Allo exposure (5 or 6 clinic visits and 6 or 7 home-nurse visits).

Conditions

• Alzheimer Dementia

Interventions

Type	Name	Description
DRUG	Allopregnanolone	Administration of weekly IM injections of Allopregnanolone.

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-12-21
• Completion: 2022-12-21
• First posted: 2018-11-20
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study