Transition Therapeutics Inc has received clearance from the US Food and Drug Administration (FDA) to initiate a phase I clinical trial for its lead Alzheimer's drug product, AZD-103. The AZD-103 compound is a possible disease-modifying therapeutic drug candidate for the treatment of Alzheimer's disease. This unique class of drug candidates may provide significant advantages over the current therapies on the market.
The phase I trial is a single blind, randomized, placebo controlled study in which healthy volunteers will receive placebo or an escalating acute dose of AZD-103. The primary objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of AZD-103. Enrolment for this trial is expected to begin September 2006.
"The AZD-103 phase I clinical trial announced April 27, 2006 has completed enrolment and Transition will release data from this study in the near future."
AZD-103 is part of an emerging class of disease-modifying drugs, which have the potential to both reduce disease progression and improve symptoms such as cognitive function.
Alzheimer's disease is a progressive brain disorder, which gradually destroys a person's memory and ability to learn reason, make judgments, communicate and carry out daily activities. The disease affects more than 4 million Americans, and with an aging population is expected to double over the next 20 years unless an effective therapy is developed.