Alzheimer's Disease: New Drug Holds Promise

The scientific community is cautiously optimistic about a new plaque-busting drug to tackle dementia and Alzheimer's disease.  Although there are other treatments on the market, this antidote is the first shown to slow and reverse the buildup of plaque in the brain which is linked to memory loss.

The results of a multi-year trial with 166 people were reported in the journal Nature, but have been largely ignored by the mainstream media.  This Phase II trial produced tantalizing data showing the drug reduces toxic plaques in six regions of the brain and slows the progression of memory loss.

Although scientists are still grappling with questions about causes of Alzheimer's, plaques and so-called tangles are prime suspects in cell death and tissue loss associated with the disease.  That's why the drug's potential for decreasing plaque is viewed as a game-changer in Alzheimer's treatment.

Up until the ground-breaking trial, the only available treatments for Alzheimers were targeted at the symptoms rather than the underlying causes.  The drugs include inhibitors, such as Pfizer's Aricept, which slow memory loss but do not reverse the disease.

The experimental drug, manufactured by pharmaceutical company Biogen, Inc., is called aducanumab.  The drug is a monoclonal antibody, which originally was harvested from brain-healthy, older donors.  Biogen now makes the drug in its laboratory to mimic the body's immune system.

Scientists theorized that the antibodies from healthy older people had already resisted the onset of dementia and Alzheimer's.  Researchers speculated these same antibodies could be used in those with early signs of memory loss, before the ravages of brain disease rendered treatment infeasible.

The peer-reviewed data from the trail rekindled new enthusiasm by clinicians and doctors to enroll their patients in aducanumab trials.  A large Phase III study was launched in August of last year, aimed at recruiting 1,350 people for trials at 150 centers in North America, Europe, Australia and Asia.

Phase III trials are designed to confirm the effectiveness of a drug, while monitoring its side effects and comparing it to other treatments. The results of the research will help quantify dosage levels for patients and assess the safety of the drug.

The next step will be garnering the stamp of approval from the Federal Drug Administration.  It is the last hurdle before aducanumab can be offered commercially to patients.

For many Americans, the drug cannot come to market fast enough. There are 5.1 million Americans with Alzheimer's disease.  Research from the National Institute of Aging indicates that Alzheimer's disease doubles every five years beyond age 65.

That is not good news because the lifespan of Americans is increasing. The Census Bureau projects the number of people age 65 and older will more than double by 2050 to 88.5 million Americans. In 34 years, the number of 85 and older people will leap three-fold to 19 million.

Those numbers underscore the urgency the scientific community feels to find a cure.  Alzheimer's is the most expensive disease to treat, costing more than cancer or heart disease.  Caring for those with Alzheimer's carries a price tag estimated at $236 billion for this year alone.

Alzheimer's disease is the sixth leading cause of death in the United States.

Unfortunately, the large-scale Phase III trial for aducanumab is expected to run until 2022.  If the results remain positive, then the approval process will begin with the FDA.  That could take years, even longer.

Meanwhile, the numbers of Alzheimer's victims will grow. Whatever can be done to speed up the trials and government approval, must be done. The clock is ticking and every year without a cure brings death, heartache and financial ruin to millions of Americans.