Clinic Trials at the Cleveland Clinic Lou Ruvo Center for Brain Health
The pace of research in the field of Alzheimer’s disease (AD) and related disorders has accelerated tremendously over the past decade. We now:
- Better understand the mechanism of the disease
- Are able to measure and image the abnormal proteins (amyloid and tau)
- Have identified genetic risk factors
- Have available symptomatic treatments
However, the ultimate goal to prevent AD will clearly require a substantial collaborative effort. Much exciting research is occurring throughout the world, with the Cleveland Clinic Lou Ruvo Center for Brain Health playing an active role. Yet, research advances also depend on the willingness of volunteers to participate in clinical trials.
Improved treatments can never become a reality without testing in human volunteers. Currently, more than 90 drugs are in clinical trials for AD, and even more are in the pipeline awaiting Food and Drug Administration (FDA) approval to enter human testing. Before any new drug or therapy can be used in clinical practice, it must be rigorously tested in humans to find out whether it is safe and effective. Today, at least 50,000 volunteers—both with and without Alzheimer’s—are urgently needed to participate in more than 175 actively enrolling Alzheimer’s disease clinical trials and studies in the U.S.
All participants receive regular care related to the study and opportunities to talk to study staff. Research shows that people involved in studies tend to do somewhat better than people in a similar stage of their disease who are not enrolled, regardless of whether the experimental treatment itself works. Scientists believe this advantage may be due to the general high quality of care provided during clinical studies.
The following studies are being conducted at the CCLRCBH. To volunteer for a trial or obtain more information regarding the research department, please call 702-483-6000.
IGIV Study (Immune Globulin Intravenous (Human))
IGIV has been successful in the treatment of a variety of autoimmune and immunodeficient diseases over the last 20 years and is believed to contain anti-amyloid antibodies. This 18 month study will help determine whether IGIV treatments will significantly slow the rate of decline in Alzheimer’s disease symptoms.
Participants for this study should be between 50 and 89 years of age with a diagnosis of mild to moderate Alzheimer’s disease and will receive an infusion of the IGIV or placebo (albumin) every two weeks for 72 weeks. Caregiver participation is necessary to monitor progress and provide feedback. IGIV has been used extensively in clinical practice for more than 20 years to treat a variety of disorders. The safety profile of IGIV is well established in hundreds of thousands of patients worldwide including many elderly individuals.
CONCERT Study
This is a 12 month study to evaluate the effectiveness and safety of an oral investigational drug, Dimebon, believed to improve the symptoms of Alzheimer’s disease. Dimebon works through a novel mechanism of action improving the function of mitochondria, the energy producing structures in cells. The study is specifically evaluating the effect of Dimebon in combination with one of the commonly used AD medications, donepezil (Aricept).
Participants of this study should be 50 years of age or older with a diagnosis of Alzheimer’s disease and currently taking donepezil (Aricept). Caregiver participation is necessary to monitor progress and provide feedback.
BMS PROTOCOL-CN156018
A 13 month study to evaluate the safety and tolerability of an investigational oral drug, BMS-708163, under development to alter the course of memory decline.
Participants of this study should be 45 years of age or older and have mild memory complaints with no diagnosis of Alzheimer’s Disease. A study partner is necessary to monitor progress and provide feedback.
KIOKU (Memory) Study
A 12 month study to evaluate an oral drug to help prevent further memory loss. Study participants should be between ages 50 and 90 years old, with a diagnosis of mild to moderate Alzheimer’s disease, and currently taking Aricept. Caregiver participation is necessary to monitor progress and provide feedback.
ADNI GO
This is a study to identify markers, either by means of imaging the brain or analyzing proteins or chemicals in spinal fluid, that would be helpful in the early detection of Alzheimer’s disease and tracking of disease progression. The study is enrolling individuals with very mild memory problems and who do not have the diagnosis of Alzheimer’s disease.