Researchers Seek New Therapies to Treat Alzheimer’s

The San Francisco Chronicle reported on November 19, 2013 that researchers who have been studying amyloid beta protein are now expanding their efforts to other proteins  in their quest for a cure for Alzheimer’s disease.  The presence of the amyloid beta protein causes clumps of sticky plaques to form in the brains of people with Alzheimer’s.  According to the Chronicle, clinical trials aimed at removing beta amyloid from the brains of Alzheimer’s patients have failed, prompting researchers to look at other approaches to treat the disease.  At Stanford University scientists are studying whether removing the LilrB2 protein or altering it may stop amyloid beta protein build up; and whether the C1Q protein, a protein known to trigger immune responses in the brain, may be stopped so that damaged synapses in the brain may have a chance to recover before the symptoms of dementia set in.  In addition, scientists at San Francisco’s Gladstone Institute of Neurological Diseases are interested in people who have a genetic risk for Alzheimer’s.  Scientists at the Gladstone Institute have substantial evidence they claim suggests that apoE4 protein actually causes conditions such as Alzheimer’s, rather than simply being linked to them.

To underscore the need for new therapies to treat Alzheimer’s disease, Janssen Pharmaceuticals Inc., a subsidiary of Johnson and Johnson, will collaborate with German pharmaceutical company Evotec AG to develop new treatments. Their goal will be to identify targets for new drugs that will focus on the disease’s  pathology, particularly in the initial stages, in the hope that new therapies will result in significant benefits to patients.  According to Leo Sun, the collaboration acknowledges that current treatments for Alzheimer’s disease are insufficient because they address the symptoms of the disease but do not treat the underlying causes.

Current medications for Alzheimer’s  treat memory loss and focus on either the early to moderate stages of the disease or the moderate to severe stages of the disease.  Other medications treat behavior and personality changes such as irritability, anxiety, and depression in the early stages of the disease.  Other behavior and personality changes in the later stages of the disease include anger, agitation, aggression, emotional distress, physical and verbal outbursts, restlessness, hallucinations, delusions, and sleep problems.  There are also several alternative therapies for the treatment of Alzheimer’s such as caprylic acid and coconut oil, coenzyme Q10, ginkgo biloba, omega-3 fatty acids, and tramiprosate. The FDA cautions users about the use of alternative therapies because they have not been through the FDA’s rigorous testing and approval procedures.  The FDA also points to potential issues regarding the products safety and effectiveness, purity, and interaction with prescribed medications.

Earlier this year the FDA released draft guidance titled “Guidance for Industry, Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease.”  The FDA intended that the guidance be used to assist companies in developing new treatments for patients that are in the early stages of Alzheimer’s disease. The guidance explains the FDA’s current position on how researchers can identify and select patients with early Alzheimer’s disease or those who are at risk of developing the disease, for participation in clinical trials. The goal for the clinical trials is to ensure that any beneficial effect on thinking is associated with an improvement or a lack of decline in how a patient feels or functions.  The guidance indicates that the FDA recognizes the need for additional therapies since the current drugs have limited effectiveness.