BACE Inhibitors Fail Safety Controls for Alzheimer’s Drugs

  • Alzheimer's drug researchClinical trials for BACE inhibitors, thought to be a possibility for Alzheimer’s treatment, were stopped last week because of potential toxicity problems. BACE inhibitors are a drug class known as beta secretase. This particular study was being conducted by Eli Lilly, though other companies have been testing similar drugs.


    The need to stop the BACE study represents another significant blow to drug companies in their race to develop the first drug to treat or prevent Alzheimer’s disease. Last fall, the injectable drug Solanezumab failed in late stage studies to slow progression of Alzheimer's among patients with mild to moderate disease.

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    Solanezumab is now being tested in patients with mild cognitive impairment (MCI) or very early stage Alzheimer's disease since it did show some promise in that particular patient population. According to an article on Reuters, a similar drug, Bapineuzumab, “has been largely written off by investors after failing to slow progression of Alzheimer's in its late-stage trials.”


    Solanezumab and Bapineuzumab were developed to potentially block beta-amyloid, which is a protein that forms brain plaques considered by many scientists to be a prime cause of Alzheimer's disease. The newer beta secretase inhibitors were meant to indirectly prevent buildup of beta-amyloid by blocking an enzyme called BACE1.


    The bottom line is that so far neither approach has been proven to work, or in the case of BACE, been proven to be safe if it did work. So now what?


    Vitamin B12, vitamin B6 and folic acid

    Last month I wrote about a study that shows promise using vitamins B12 and B6 as well as folic acid that are already available and have been established as safe for human consumption.


    "The Proceedings of the National Academy of Sciences recently published information about a study on aging volunteers that has demonstrated how this combination of B vitamins has, in their trials, slowed atrophy of gray matter in brain areas affected by Alzheimer’s disease. In the words of senior study author A. David Smith, professor emeritus of pharmacology at Oxford University in England, 'It’s a big effect, much bigger than we would have dreamt of.'"

    This treatment needs further study, but shows enough promise that, with the blessings of our doctors, we should at the very least make sure we are ingesting enough of these vital nutrients to maintain overall health.


    Exercise and diet

    Last summer researchers at Kyoto University Graduate School of Medicine in Japan concluded in a study done with mice that exercise is looking promising as one way to potentially prevent Alzheimer’s disease. Most physicians and scientists will likely support the idea that exercise may help keep the brain healthy, since it’s proven to help the heart. Heart health and brain health are closely related.


    In May, lead researcher Dr. Georgios Tsivgoulis, from the University of Alabama at Birmingham as well as the University of Athens, Greece, said after seeing the results of his own study, that "Greater adherence to Mediterranean diet was associated with lower risk of incident cognitive impairment in this large population-based study.” 


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    A Mediterranean diet consists of olive oil, nuts, fish, tomatoes, poultry, cruciferous vegetables, fruit, and dark and green leafy vegetables. In general, low amounts of high fat dairy products, red meat, organ meats and butter are consumed.


    What we can do while we await a "miracle drug"

    Alzheimer’s advocates work to provide funding for researchers working on drugs or therapies that may prevent or cure Alzheimer’s disease. We can’t allow these failed drug studies to feed hopelessness in the face of the exploding numbers of Alzheimer’s cases.


    While we wait, however, we would do well to focus on what we can do now. Proper exercise and diet, plus supplements used judiciously under the guidance of a qualified physician, can at the very least, give us a chance to stay healthy while we await a pharmaceutical breakthrough.


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    Pierson, R. (2013, June 13) Lilly halts Alzheimer's drug trial due to liver problems. Reuters. Retrieved from


    Gerlin, A. (2013, May 20) Vitamins That Cost Pennies a Day Seen Delaying Dementia. BloombergBusinessweek. Retrieved from

    American Society for Biochemistry and Molecular Biology (2012, June 27) Exercise is key in the fight against Alzheimer's disease. Retrieved from 

    McMaster University, CA (2011, February 18) Endurance Exercise Prevents Premature Aging. Retrieved from[status]=3&search[sort]=date+desc&search[has_multimedia]=

Published On: June 17, 2013