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From the Department of Neurology, Georgetown University Medical Center, Washington DC (P.S.A.); and Neurochem Inc., Laval, Quebec, Canada (D.S., R.B., J.L., F.G., P.T., D.G.).
Address correspondence and reprint requests to Dr. Daniel Saumier, 275, boul. Armand-Frappier, Laval, QC, Canada H7V 4A7; e-mail: dsaumier{at}neurochem.com
Background: As a potential disease-modifying treatment for Alzheimer disease (AD), 3-amino-1-propanesulfonic acid (3APS) is a compound that binds to amyloid ß (Aß), a toxic protein known to aggregate, leading to amyloid plaque deposition in the brain.
Methods: We assessed the safety, tolerability, and pharmacokinetic/pharmacodynamic effect of 3APS in a randomized, double-blind, placebo-controlled Phase II study in which 58 subjects with mild-to-moderate AD were randomly assigned to receive placebo or 3APS 50, 100, or 150 mg BID for 3 months. At the end of the double-blind phase, 42 of these subjects entered an open-label phase in which they received 3APS 150 mg BID for 17 months. Assessments included plasma and CSF 3APS concentrations, CSF levels of Aß (Aß40 and Aß42), and total tau, as well as cognitive (Alzheimer’s Disease Assessment Scale–cognitive subscale, Mini-Mental State Examination) and clinical (Clinical Dementia Rating scale–Sum of Boxes) measures.
Results: 3APS had no significant impact on vital signs or laboratory test values. The most frequent side effects were nausea, vomiting, and diarrhea, which were intermittent and mild to moderate in severity. Seven 3APS-treated subjects discontinued because of side effects (all causalities) over the course of the study, and there were no 3APS-related serious adverse events. 3APS crossed the blood–brain barrier, and dose-dependently reduced CSF Aß42 levels after 3 months of treatment. There were no psychometric score differences between groups over the 3-month double-blind period.
Conclusion: Long-term administration of 3-amino-1-propanesulfonic acid is safe, tolerated and reduces CSF Aß42 levels in patients with mild-to-moderate Alzheimer disease.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the November 28 issue to find the title link for this article.
This article was previously published in electronic format as an Expedited E-Pub at www.neurology.org
Disclosure: Dr. Aisen is a consultant for and has received honoraria from Neurochem Inc. Dr. Aisen has also received grants in excess of $10,000 from Neurochem Inc. Daniel Saumier, Richard Briand, Julie Laurin, and Denis Garceau are employees of Neurochem Inc. Francine Gervais and Patrick Tremblay are former employees of Neurochem Inc.
Received August 18, 2005. Accepted in final form July 26, 2006.
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