Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-384 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ABT-384 Dose 1 | EXPERIMENTAL | - |
| ABT-384 Dose 2 | EXPERIMENTAL | - |
| donepezil | ACTIVE_COMPARATOR | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ABT-384 | DRUG | Subjects will take study drug once daily for 12 weeks |
| donepezil | DRUG | Subjects will take study drug once daily for 12 weeks. |
| placebo | DRUG | Subjects will take study drug once daily for 12 weeks |
Inclusion Criteria: 1. The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject. 2. Subject is male or female between the ages...
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ABT-384 was developed for the treatment of mild-to-moderate Alzheimer's disease. It is an investigational small molecule that was studied in a Phase 2 clinical trial in adults aged 55 years and older. It is not an approved therapy.
ABT-384 targets HSD11B1, also known as 11-beta-hydroxysteroid dehydrogenase type 1. It acts as an inhibitor of this enzyme. Inhibiting HSD11B1 was the intended mechanism explored in Alzheimer's disease research.
ABT-384 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the company responsible for the clinical development of this investigational Alzheimer's disease candidate.
ABT-384 reached Phase 2 clinical development. The single Phase 2 trial has been completed, and there are no active trials. ABT-384 is investigational and has not been approved by the FDA for any indication.
ABT-384 was studied in one completed Phase 2 trial, NCT01137526, titled Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease. It enrolled 267 participants across Russia, South Africa, Ukraine, and the United Kingdom.
Yes. The Phase 2 trial NCT01137526 was randomized, double blind, and placebo controlled. It enrolled 267 participants with mild-to-moderate Alzheimer's disease, included both sexes, and required a minimum age of 55 years. Healthy volunteers were not enrolled.