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New Treatments in Progress

Clinical Phases

    • Pre-clinical—drugs are studied in test tube situations or on animal models
    • Phase I—tested on a small number of healthy humans to see what a safe dose would be
    • Phase II—testing safety and effectiveness in a small number of patients; not enough people to justify it being used by everyone with the condition
    • Phase III—large scale trial designed to test safety and effectiveness that would be adequate for FDA approval
    • Submit testing results for FDA approval
    • Phase IV—post-approval studies done to make sure the treatment is safe and to promote further investigations
    • Drugs must go through clinical trials in phases before being approved for usage in the U.S.

Research Categories

Categories of on-going research:

  • Cat I—decreasing amyloid production
  • Cat II—decreasing deposits of amyloid plaque
  • Cat III—promoting clearance of amyloid plaque

According to Dr. Norman Relkin, a prominent physician and researcher in the field of Alzheimer's disease, there are several treatments currently in clinical trial phases that are showing promise in the treatment of Alzheimer's disease. Dr. Relkin is the director of the Weill Cornell Memory Disorders Program in New York City and is currently leading the North American clinical trial of Human Antibodies, sponsored by the NIH.

In a March 21 presentation he made in New York for an educational conference, Dr. Relkin described the latest thinking about strategies to control or resolve the disease once it is identified. He commented that previous research focused on managing the chemical imbalance caused by the identified reduction in acetylcholine found in the brains of people with symptoms of Alzheimer's disease. This research has provided drugs that tried to help the brain after the disease process was welladvanced and treated the neurochemical deficit, not the actual disease process. They are designed to chemically help the brain function in spite of the disease.

These drugs include the acetylcholinesterase inhibitors (Aricept, Exelon, and Razadyne) and NMDA antagonist (Namenda). The acetylcholinesterase inhibitors help the brain by tricking some of the enzymes that bind the chemical acetylcholine and make it more available to the brain to form memories and function.

The NMDA antagonist provides a control to prevent cells from picking up too much glutamate, which causes more chemical difficulties. Neither group of medications is meant to fix or restore normal cell function, but they have certainly provided symptom relief for many people with dementia.

Changing Focus

Dr. Relkin indicated that in the late 1990's and early 2000's the thinking changed about how to help with the disease and how to potentially control it or reverse it. The focus moved first to trying to remove or rid the system of amyloid plaque formations. Research focused on the possibility of using antiinflammatory medications, hormone replacement medications, and anti-oxidants to possibly stop or even prevent the condition from occurring.

During this period, there was also work to consider the use of a vaccine to remove the amyloid plaques. Unfortunately, most of the research did not have significant impact on people with the condition. The vaccine, successful in animal studies, resulted in deaths and negative outcomes for humans, although significant reduction in plaque formations occurred in those treated with the vaccine.

Dr. Relkin reported that current research is based on a modified beta-amyloid hypothesis that is focusing on protein mis-folding and is directed more toward preventing beta amyloid formations (aggregation) or preventing their clumping (deposition) near brain cells. He indicated that there are several medications or treatments in clinical trials that are showing some promise.

Treatment Approaches

Dr. Relkin reported that there are three categories of anti-amyloid treatment approaches currently in clinical trials.

The first category is investigating treatment that will decrease amyloid production—Flurizan (phase III) and LY450139 (phase II).

The second category is investigating decreasing amyloid fibril deposits—Alzemed (phase III). The third category is investigating techniques to promote amyloid clearance—ACC-001(phase I); AAB-001 (phase II); and IVIG- human immunoglobulin (phase II).

He also noted other trials that were ongoing that have importance in the possible treatment of dementia:

  • anti-cholesterol medications (Lipitor) in phase II, curcumin (curry) in phase I & II,
  • gingko biloba in phase III,
  • rosiglitizone (anti-type-II diabetes medication) in phase II
  • TTP448—RAGE inhibitor in phase II.

These studies are showing varying degrees of effectiveness—one new treatment may be available as early as 2008 or 2009.

Conclusions

Overall, Dr. Relkin reported there are over 500 industry-sponsored studies that are on-going related to dementia and Alzheimer's disease. He indicated that there are over 70 clinical trials going on in the U.S. at this time. He also reported that funding had improved from the federal government, but that much more is needed, given the rapid increase in numbers and the anticipated rise over the next 10-20 years. His talk provided some insights into what the current state of treatment research is for medications and interventions to prevent or improve the underlying factors that cause Alzheimer's disease. Within the next few years we may have new tools to help people who are developing this condition.

His final words of wisdom however were that prevention would be achieved through a combination of dietary intervention, mental stimulation, and promotion of an active lifestyle as well as individualized pharmacological intervention. In other words, we will have to work at it, there is no silver bullet!

Want to Participate?

To learn about clinical trials being conducted in your area and if you or a loved one qualify, visit the NIH's Clinical Trials web site www.ClinicalTrials.gov, and type in a search term such as Alzheimer's or dementia.

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