First clinical evaluation of ganstigmine in patients with probable Alzheimer's disease

Clinical Neuropharmacology
S JheeT Shiovitz

Abstract

The objective of this study was to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of five fixed doses of ganstigmine (CHF 2819) in patients with probable Alzheimer's disease (AD). This randomized, double-blind, placebo-controlled trial evaluated five dose levels (5, 7.5, 10, 12.5, and 15 mg) administered orally once daily for 7 days. Adverse events and continuous telemetry were collected on successive panels of six patients (five active, one placebo). Acetylcholinesterase, butyrylcholinesterase, and plasma drug levels were measured. A total of 29 patients were randomized and 18 completed the study. A total of seven patients, including five of five in the 12.5-mg panel, discontinued because of adverse events. Four patients were withdrawn administratively from the first panel while an episode of atrial fibrillation (the only serious adverse event) was investigated. This panel was then repeated. Mild, transient headache or nausea were the most commonly reported adverse events. Multiple moderate adverse events in the 12.5-mg panel (including nausea, vomiting, and anorexia) led to the decision not to proceed with a 15-mg panel. Ten milligrams was determined to be the maximum tolerat...Continue Reading

References

Apr 1, 1995·Journal of Geriatric Psychiatry and Neurology·W E Reichman, A C Coyne
Jan 1, 1995·European Journal of Clinical Pharmacology·N R Cutler, J J Sramek

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Citations

May 19, 2010·Biomarkers in Medicine·Larry EreshefskyJames Adams
Dec 24, 2005·Expert Opinion on Investigational Drugs·Ana Martinez, Ana Castro
Dec 10, 2003·International Journal of Geriatric Psychiatry

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