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news.Biopharmaceutical CNS treatments developer Memory Pharmaceuticals has initiated a safety and tolerability study of its experimental Alzheimer's disease treatment, MEM 1003.
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The study is being conducted under an investigational new drug (IND) application that Memory Pharmaceuticals filed with the FDA in mid-November 2004.
The safety and tolerability study is a single center, placebo-controlled clinical study and is being conducted at the Clinical Research Institute in Wichita, Kansas under the direction of Dr Sheldon Preskorn, president and CEO of the Clinical Research Institute.
The study design consists of two phases, a double-blind dose escalation phase and double-blind treatment phase. Up to 32 patients will be enrolled in each phase of the study.
The first phase will be approximately six weeks in duration and MEM 1003 or placebo will be administered to patients two times on one day of certain weeks during that period. Patients in the first phase will be treated at escalating doses that could reach up to 120mg per dose.
The highest tolerated dose of MEM 1003 in the first phase will then be administered to the up to 32 patients participating in the second phase of the study. Dosing in the second phase will occur twice daily for a period of ten days.
A secondary objective of the safety and tolerability study is to evaluate the acute neurocognitive function in the Alzheimer’s disease (AD) patients using a battery of standard cognitive tests.
Pharmacokinetic measurements and other observations from this study, including the results of the cognitive tests, will be used to finalize dose selection and design details of the phase IIa efficacy study which is scheduled to commence by the end of the first half of 2005.
Dr David Lowe, chief scientific officer of Memory Pharmaceuticals, commented, “We are pleased that this important dose escalation study in AD patients has begun. MEM 1003 is a potentially important compound for the treatment of this debilitating disease.”
The IND application that was filed with the FDA for the safety and tolerability study included the results of the two double-blind, randomized, placebo controlled phase I clinical trials for MEM 1003 that were completed in the UK.