NEW YORK (Reuters Health) - The investigational drug Alzhemed continues to show promise in not only addressing the symptoms but also in blocking the progression of Alzheimer’s disease (AD), according to results presented at the Ninth International Conference on Alzheimer’s Disease and Related Disorders in Philadelphia.
In the latest results reported Sunday, 70% of patients with mild-to-moderate AD (n=19) saw their cognitive function stabilize or improve over 20 months of oral Alzhemed treatment.
Unlike existing AD therapies, Alzhemed targets the core pathology of the disease - beta-amyloid plaque formation in the brain, Dr. Paul Aisen from Georgetown University in Washington, D.C., explained in a telephone interview with Reuters Health. “It’s a small molecule that gets into the brain where it binds to the amyloid peptide,” he said.
“Alzhemed represents the most advanced development of anti-amyloid drugs,” he continued. The drug is being developed by Montreal-based Neurochem Inc.
In the laboratory, Alzhemed blocks the fibrillization of the amyloid peptide and in transgenic mice it reduces levels of amyloid in the brain. In initial phase II studies in humans, Alzhemed was safe and well-tolerated, significantly reduced amyloid levels in the cerebrospinal fluid, and stabilized or improved cognitive function.
In the open-label phase II extension study reported Sunday, “patients are continuing to do well,” Dr. Aisen said. “They have a stable clinical course compared to expectations.”
The data are based on the evaluation of cognitive performance as measured by the Alzheimer’s Disease Assessment Scale (ADAS-cog), which measures patients’ memory, orientation, reasoning and language, and global performance as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scores.
Specifically, the 19 mild-to-moderate AD patients treated with Alzhemed saw an average change from baseline of 6.2 points on the ADAS-cog scale after 20 months as opposed to 11.9 points expected, a difference of more than 5 points. A subset of 10 patients with mild AD showed the greatest benefit, with a change in ADAS-cog of only 2.4 points in 20 months.
The average CDR-SB score in the mild-to-moderate AD patients after 20 months of treatment showed 2.7-point change, which compared favorably with a 2.2-point deterioration expected after only 12 months in historical AD controls.
Overall, the results at 20 months compared favorably with results reported at 12 months (see Reuters Health report April 14, 2004). The most frequent side effect was nausea and vomiting, which occurred early after the start of treatment and decreased over time.
Based on these promising results, Neurochem Inc. last month launched a phase III study in 70 clinical centers in North America.
“This is a three-arm, parallel-group randomized trial in which Alzhemed - 100 or 150 mg twice per day - will be added to standard therapy for 18 months,” Dr. Aisen said. “This will be the pivotal study of the efficacy of Alzhemed,” he added. Investigators plan to enroll 950 AD patients in this trial.
Neurochem also plans to launch a similar phase III trial in Europe in early 2005.
MeSH Headings:Amyloid: Congresses: Health Care Economics and Organizations: Organizations: Health CareCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
