New investigational drug can slow memory loss in older Individuals with risk for developing AD in future

Jun 17 2014

A new research study at Rush University Medical Center and Northwestern Medicine is testing whether a new investigational treatment can slow the memory loss caused by Alzheimer's disease.

The study will include men and women ages 65 to 85 who have normal thinking and memory function but who may be at risk for developing Alzheimer's disease (AD) memory loss sometime in the future.

The purpose of the research study, called the Anti-Amyloid Treatment in Asymptomatic Alzheimer's study (the "A4 study" for short), is to test whether a new investigational drug, called an amyloid antibody, can slow memory loss caused by Alzheimer's disease.

Amyloid is a protein normally produced in the brain that can build up in older people, forming amyloid plaque deposits. Scientists believe this buildup of deposits may play a key role in the eventual development of Alzheimer's disease-related memory loss and dementia. The overall goal of the A4 study is to test whether decreasing amyloid with antibody investigational drug can help slow the memory loss associated with amyloid buildup in some people.

"There exists no effective preventive treatment for Alzheimer's disease, which we now know may be an underlying cause of five to six times as many deaths than commonly reported, said Dr. Neelum Aggarwal, a neurologist and Rush site principal investigator. "This new study gives us hope, but we need to increase our efforts, both in the hospital clinics and in the community, to enroll a diverse group of study participants including Hispanic, Caucasian, African-American males and females to understand the specific outcomes of this study on each group."

The A4 study institutions are beginning to enroll participants at more than 60 sites throughout the U.S., Canada and in Australia. Rush and Northwestern are the only two Illinois sites for the study.

Dr. Sandra Weintraub, neuropsychologist and Northwestern Feinberg School of Medicine site principal investigator, stated: "The A4 trial is a landmark study to prevent Alzheimer's disease. To date, our focus has been on trying to cure the disease but we have learned that by the time memory loss appears, it is too late. The information we gain from the A4 study will help us to know if it is possible to stop the disease before it affects thinking abilities and daily functioning. Northwestern is committed to working shoulder-to-shoulder with Rush to bring this ground-breaking research to all the diverse communities represented in the Chicagoland area. Having two study sites in Chicago allows us to open up more opportunities for more people to participate."

Participants who are selected for the study will be assigned at random to receive either the investigational drug or a placebo and will be monitored over the three-year duration of the study that is designed to evaluate the effectiveness, safety and tolerability of the investigational drug, Solanezumab, for AD.

Solanezumab is an antibody that helps the brain clear amyloid and may also prevent amyloid plaques from forming. It has been tested in individuals with Alzheimer's dementia but at that point treatment may have been too late because memory has already been damaged to the point that is irreversible.

Individuals interested in the study should have no outward signs of Alzheimer's dementia or early memory loss that leads to the dementia but must be cognitively normal for their age and have an "elevated" level of amyloid plaque in their brain. Physicians and researchers will use an imaging test called a PET scan to determine whether a potential participant has evidence of this amyloid buildup. People who do not show evidence of elevated amyloid in their brains will not be able to participate, but may be asked to participate in a separate study. This group will not receive the investigational drug or placebo (i.e., an inactive substance designed to mimic the appearance of a drug), but will complete the same memory tests every six months to compare changes in cognition over time.