Clinicians at the Roskamp Institute are conducting a clinical trial for Elan Pharmaceuticals, Inc. of San Francisco and Transition Therapeutics, Inc. of Toronto, Canada.
The drug is designated ELND005 and the study is a phase two study in mild to moderate Alzheimer’s disease. ELND005 is an orally available drug that is designed to prevent the aggregation of the amyloid peptide. The amyloid peptide is thought to be central to the disease process in Alzheimer’s disease.
As the amyloid peptide accumulates in the brain in Alzheimer’s disease patients, it forms aggregates which are toxic to neurons. ELND005, which was formally known as AZD103, was developed in collaboration with transition therapeutics and has been shown to be able to reduce the amount of amyloid that accumulates in the brains of transgenic mouse models of the disease. This reduction in accumulation correlates with improved memory testing in such animals.
Phase I studies have already been completed in healthy volunteers with ELND005. The drug is shown to be well tolerated and crosses the blood/brain barrier. Importantly, ELND005 has been shown to reach CSF concentrations in humans that are equivalent to the effective mouse concentrations that can reduce the burden of amyloid in mice.
The Phase II study design includes three treatment arms and one placebo group. The treatment arms receive twice a day oral dosing of ELND005. The dose is either 250 mg, 1000 mg, or 2000 mg. The treatment phase will last for 78 weeks.
The endpoints of the study will include cognitive and functional testing of mild to moderate Alzheimer’s disease patients and MRI imaging of brain volumes. Quality of life measures will also be included. As in all Phase II studies, safety will be a primary measure throughout the clinical trial.
Clinical researchers at the Roskamp Institute are committed to bringing new drug treatments like ELND005 to our Alzheimer’s population. It is hoped that either this drug or others like it will play a significant role in the control of Alzheimer’s disease in the near future.
The Roskamp Institute is developing its own drug therapies for Alzheimer’s disease. One of which, nilvadipine, is currently under clinical trials in Ireland. This drug is shortly to be brought into clinical trials in the United States pending FDA approval.