KALAMAZOO, MI – For years Alzheimer’s researchers have focused on testing experimental drugs on patients who already have a diagnosis of Alzheimer’s and significant changes in cognition, memory and behavior. It has become quite clear that researchers have been trying to treat the disease at too late a stage. They agree that they need to be focusing on the very earliest stage, what is called “prodromal AD,” when patients suffer little or no cognitive or memory loss but scans show that their brains contain beta amyloid, the sticky plaques that are the hallmark of the disease that destroy healthy neurons.

“In the past, people with prodromal Alzheimer’s disease would not have been considered to have Alzheimer’s based on the previous criteria,” says Phillip Green, MD, Medical Director of Neurology Research at Borgess Research Institute. “Now we recognize that the prodomal state is the initial part of the continuum to full blown Alzheimer’s.  We feel it’s like an iceberg as changes are going on underneath the surface of awareness of Alzheimer’s before it’s expressed. It is felt that amyloid plays a role in the progression of the disease and that if caught early the progression will be influenced.”

More research is focusing on the early prodromal phase. The Scarlet Road Study, currently enrolling patients at Borgess Research Institute, is one such innovative study. Scarlet Road, Green says, is a double-blind, placebo-controlled study that will test the effect of injections of an experimental drug, gantenerumab, or placebo on people who have prodromal Alzheimer’s disease. Gantenerumab is a new experimental drug made from human antibodies, a type of protein produced by the human immune system in response to a foreign substance such as a virus or bacteria.  Antibodies protect the body from disease by attacking these substances and destroying them. Gantenerumab has been developed to attack the beta-amyloid plaques in the brain.

The Borgess Research Institute study will run over a two and a half year period. One third of study participants will receive a low drug dose, one third will receive a moderate drug dose and the remaining group will receive the placebo. Most studies follow a 50/50 drug to placebo formula; in this study participants have a two in three chance of receiving the actual experimental drug. Neither participants or study staff will know who is receiving the study drug and who is receiving the placebo.

For further information on the Scarlet Road Study, call (269) 226.4803 or go to research.borgess.com.

About 18 million people worldwide suffer from Alzheimer’s disease. At present, doctors and researchers do not fully understand the cause of this degenerative disease.

Symptoms often include the progressive loss of memory and judgment, changes in personality, anxiety, or even suspiciousness and delusion. Over time, patients may lose their ability to swallow and eat solid foods, or they may become incontinent.

Researchers, therefore, continue to conduct studies in Alzheimer’s disease at its earliest possible stages. Researchers at Borgess Research Institute, headed by Dr. Phillip Green, are conducting a clinical research study to test the safety and tolerability of an investigational medication for Alzheimer’s disease. They will test different doses of the investigational medication compared to an inactive substance (placebo).

“If the person you care for is suffering from symptoms of Alzheimer’s disease, we encourage you to talk to his or her doctor about clinical studies or to contact us for more information on this particular study to see if the person is eligible,” said Dr. Phillip Green.

Eligible participants must be 50 to 89 years old with a diagnosis of probable Alzheimer’s disease. Participants must live at home or in a community dwelling with an appropriate caregiver who can accompany him or her on all study clinic visits and visit them at least 5 times a week. Other medical criteria will be evaluated by the study staff at the clinic to determine eligibility.

The study is being conducted at approximately 12 clinics across the U.S. and the study seeks to enroll about 80 subjects.

Study participation lasts about 47 weeks and includes approximately 15 visits to the study doctor and 6 telephone contacts. The investigational medication is given via a 1-hour IV infusion once every 13 weeks up to 3 times during the study. Qualified study participants will not be charged for study-related office visits, medical evaluations, or study medication. Qualified participants may also receive payment.

For more information about this Alzheimer’s study, please call the Borgess Research Institute at 269-226-4803 or visit research.borgess.com or visit www.ALZresearch.com.