When it comes to Alzheimer’s treatment, where does the hype end and the future begin? A panel of leading experts in Alzheimer’s disease talk about the treatment approaches with the most promising early data in a new report, “Thought Leader Insight & Analysis: Alzheimer’s Disease.” The report discusses acetylcholinesterase (butyrylcholinesterase) inhibitors, NMDA, M1, 5-HT, alpha-7 nicotinic acetylcholine agonists, active and passive immunotherapy, gamma-secretase and beta-secretase inhibitors, insulin related mechanisms (IDE, RAGE), plasminogen activator inhibitor-1, anti-TNF, GSK3 and more.
Some of the companies discussed in this report include General Electric, Bateman/Holtzman, Bayer-Schering/Avid Radiopharmaceuticals, Satoris, Neurochem, Sanofi-Aventis, Eisai/Pfizer, Novartis, J&J, Debio, TorreyPines, Forest/Merz/Lundbeck/Daiichi-Sankyo, Medivation, Merck, GSK, Neuropharma/Zeltia, Abbott, AstraZeneca, Roche/Memory, EnVivo/Bayer-Schering, Baxter, Elan/Wyeth, Lilly, Pfizer, Eisai/BioArctic, Roche/Morphosys, AC Immune/Genentech, Affiris, AC Immune, Boehringer-Ingelheim/Ablynx, Lundbeck/Pharmexa, Myriad, Lilly/Elan, Wyeth , Schering-Plough, Elan, BMS, TorreyPines, Cellzome/J&J, CoMentis, Sunesis/Merck, Astex/AstraZeneca, Amgen, Wyeth/Amgen, TransTec/Pfizer, Accera, Sirtris, Neuropharma, Prana, Epix/GSK, and Elan/Transition Therapeutics.
“Thought Leader Insight & Analysis: Alzheimer’s Disease” can be ordered from MedPredict, which produces similar reports in other areas using its proprietary database of over 1,000 global physician thought leaders, including 40+ specialties in 30+ therapeutic categories. Of course, the price of the report is US $6,000. Is that tax-deductible? Can I get a discount from Amazon? Will they have a summary of the report in the AARP magazine, or would it lack the baby boomer appeal?
Medivation, Inc. (NASDAQ:MDVN) has announced that the U.S. Food and Drug Administration (FDA) will let them use their company’s previously completed trial conducted in Russia as one of the studies required to support the approval of Dimebon to treat mild-to-moderate Alzheimer’s disease. The FDA says that a significant proportion of the sites in the confirmatory Phase 3 trial, to be conducted in the second quarter of 2008, must be located in the United States.
About 525 patients with mild-to-moderate Alzheimer’s disease in the United States, Europe and South America will participate in the next phase of the study. Test groups will take medication three times a day: either 20 mg of Dimebon, 5 mg Dimebon, or a placebo (sugar pill). For six months, patients in the text may not be taking any other Alzheimer’s disease drugs.
In the previously completed trial, Dimebon-treated patients were significantly improved over placebo patients on both the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Clinician’s Interview-Based Impression of Change plus caregiver interview (CIBIC-plus). The level of statistical significance was several times better than what is required to obtain marketing approval. Still, these sound like the kind of tests I’m skeptical of, where a elderly person could get a different score each time simply if they have insomnia, depression, or a hangover. What if I don’t feel like being tested? Is grumpy the same as mentally impaired? Sometimes it can sure look like it.
Beside having record sales and earnings for 2007, Baxter International Inc. (NYSE:BAX) is proud of the completion of a phase II study of their intravenous Alzheimer’s drug Gammagard. It was tested for six months with 24 patients with mild to moderate Alzheimer’s disease. The company says, “Cognitive, behavioral and functional measures were collected at baseline, three months and six months of treatment. The primary endpoints of the Phase II trial were cognitive function (as measured by ADAS-Cog score) and global function (as assessed by ADCS-CGIC rating).” But they won’t present the final results until the second quarter of 2008.
According a Dow Jones story for Morningstar investors, Gammagard is a “decades-old Baxter drug now used to treat malfunctioning immune systems.” It’s classified as an intravenous immunoglobulin, or IVIG, drug, which means it’s chock-full of natural human antibodies. Theoretically, it helps Alzheimer’s patients rebuild their depleted stock of antibodies that could remove plaque from their brains. Even though Gammagard is produced from humans, not from chemicals, Baxter insists that they can provide enough of it to meet market demands.