Therapeutics

ABT-384

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Overview

Name: ABT-384
Therapy Type: Small Molecule (timeline)
Target Type: Other (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Discontinued)
Company: AbbVie

Background

This is a selective 11-β-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor that was evaluated to test the hypothesis that elevated cortisol levels in the brain contribute to cognitive impairment. 

Findings

In 2009 and 2010, Abbvie conducted two phase 1 studies to evaluate safety, pharmacokinetics and -dynamics in healthy and elderly participants (Liu et al., 2013; Katz et al., 2013).

Between May 2010 and July 2011, Abbvie ran a multicenter Phase 2 trial. Conducted at 30 sites in four different countries, it compared 10 and 50 mg of ABT-384 or placebo, given once-daily for three months, in people with mild to moderate Alzheimer's disease for change from baseline on the ADAScog13. After randomizing 267 participants, the study was stopped for futility. Neither dose of ABT-384 affected cognitive performance; whereas the active comparator donepezil did (Marek et al., 2014). No further development was reported. 

Last Updated: 29 Nov 2019

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References

Therapeutics Citations

  1. Donepezil

Paper Citations

  1. Liu W, Katz DA, Locke C, Daszkowski D, Wang Y, Rieser MJ, Awni W, Marek GJ, Dutta S. Clinical Safety, Pharmacokinetics, and Pharmacodynamics of the 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor ABT-384 in Healthy Volunteers and Elderly Adults. Clin Pharmacol Drug Dev. 2013 Apr;2(2):133-51. Epub 2013 Feb 21 PubMed.
  2. Katz DA, Liu W, Locke C, Jacobson P, Barnes DM, Basu R, An G, Rieser MJ, Daszkowski D, Groves F, Heneghan G, Shah A, Gevorkyan H, Jhee SS, Ereshefsky L, Marek GJ. Peripheral and central nervous system inhibition of 11β-hydroxysteroid dehydrogenase type 1 in man by the novel inhibitor ABT-384. Transl Psychiatry. 2013 Aug 27;3:e295. PubMed.
  3. Marek GJ, Katz DA, Meier A, Greco N 4th, Zhang W, Liu W, Lenz RA. Efficacy and safety evaluation of HSD-1 inhibitor ABT-384 in Alzheimer's disease. Alzheimers Dement. 2014 Jan 10; PubMed.

Further Reading

No Available Further Reading