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Home: Drug Development: Drugs in Clinical Trials
Drugs In Clinical Trials

Important Notice: The Forum does not endorse any medical product or therapy. ALL medications and supplements should be taken ONLY under the supervision of a physician, due to the possibility of side-effects, drug interactions, etc.

Name: Eptastigmine
Other Names: MF 201
Development Status: investigational in U.S.
FDA Phase: Discontinued
Primary Medical Role: Prevent cognitive deterioration in AD.
Role in Alzheimer's Disease: Improve cognition.
Pharmacological Role: A long-acting cholinesterase inhibitor.
Side Effects: Mild, with agitation, insomnia, nausea, and dizziness described at different rates, slightly more than placebo group.
Evidence pro its efficacy: Short-term, Phase III, randomized, double-blind, placebo- controlled, parallel group study showed significant improvement in ADAS-Cog to 25 weeks.
Evidence con its efficacy: Eptastigmine did not provide any protection against sarin toxicity.
Dosage: 40-60 mg/day investigated
Companies: Mediolanum Pharmaceuticals
Notes: The adverse hematologic (granulocytopenia) effects reported in two studies have resulted in the suspension of further clinical trials for eptastigmine.

References

Braida D, Sala M. Eptastigmine: ten years of pharmacology, toxicology, pharmacokinetic, and clinical studies. CNS Drug Rev. 2001 Winter;7(4):369-86. Abstract

Imbimbo BP, Troetel WM, Martelli P, Lucchelli F. A 6- month, double-blind, placebo-controlled trial of eptastigmine in Alzheimer's disease. Dement Geriatr Cogn Disord. 2000 Jan-Feb;11(1):17-24. Abstract

Imbimbo BP, Martelli P, Troetel WM, Lucchelli F, Lucca U, Thal LJ. Efficacy and safety of eptastigmine for the treatment of patients with Alzheimer's disease. Neurology. 1999 Mar 10;52(4):700-8. Abstract

Imbimbo BP, Verdelli G, Martelli P, Marchesini D. Two-year treatment of Alzheimer's disease with eptastigmine. The Eptastigmine Study Group. Dement Geriatr Cogn Disord. 1999 Mar-Apr;10(2):139-47. Abstract

Mant T, Troetel WM, Imbimbo BP. Maximum tolerated dose and pharmacodynamics of eptastigmine in elderly healthy volunteers. J Clin Pharmacol. 1998 Jul;38(7):610-7. Abstract

Canal N, Imbimbo BP. Relationship between pharmacodynamic activity and cognitive effects of eptastigmine in patients with Alzheimer's disease. Eptastigmine Study Group. Clin Pharmacol Ther. 1996 Aug;60(2):218-28. Abstract


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