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Phase III
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Phase III interventional trials

Phase III clinical studies provide the chief evidence for safety and effectiveness that the U.S. Food and Drug Administration (FDA) considers in deciding whether to approve a drug. The following Alzheimer drugs in Phase III clinical studies are “interventional drugs” designed to slow or stop the progression of the disease.

Other types of interventional studies evaluate investigational medications that focus on treating symptoms or preventing the disease. Interventional studies are different from observational studies, in which researchers can only observe what happens to a group or groups of people undergoing a particular treatment and then record the outcomes.

  • Bapineuzumab is designed to bind to and remove the beta-amyloid peptide that accumulates in the brains of individuals with Alzheimer's. Bapineuzumab is given as a series of injections, delivering antibodies to beta-amyloid. This approach is called “passive immunization,” since the body is receiving the antibodies via the drug, rather than generating the antibodies itself. This drug is being tested in individuals with mild to moderate Alzheimer's. Approximately 4,000 subjects at more than 350 sites worldwide (include 200 sites in the United States and Canada) are expected to participate.
    Trial details at ClinicalTrials.gov

  • Dimebon improves the function of mitochondria in the brain. Mitochondria are the central energy source of all cells. Impaired mitochondrial function may contribute to the loss of brain cell function in Alzheimer's. In a one-year, placebo-controlled trial of patients with mild-to-moderate Alzheimer's, Dimebon improved cognition and memory, activities of daily living and behavior. Study volunteers who received Dimebon for 12 months and continued on Dimebon for an additional six months had preservation of function close to their starting baseline levels on key signs and symptoms of Alzheimer's. Study volunteers in the placebo group who transferred to Dimebon after 12 months also experienced stabilization of cognitive function. The study seeks approximately 525 volunteers with mild-to-moderate Alzheimer's.
    Trial details at ClinicalTrials.gov  

  • Intravenous immunoglobulin (IVIg), a product derived from human donor blood, contains natural anti-beta-amyloid antibodies that may reduce beta-amyloid levels in the brain and improve cognition in Alzheimer’s. It is approved by the FDA for the treatment of a variety of autoimmune and immune deficiency diseases, but not yet approved for Alzheimer’s. The study is recruiting 360 volunteers with mild-to-moderate Alzheimer’s disease at 33 study locations across the United States.
    Trial details at ClinicalTrials.gov

  • Resveratrol, a naturally occurring polyphenol found in red wine, has been found in some studies to increase cognition, reduce degeneration of neurons and help clear beta-amyloid from the brain. Several observational studies have shown that moderate consumption of wine is associated with a lower incidence of Alzheimer's disease. Resveratrol may have antioxidant and neuroprotective properties. Participants in this study will receive either a placebo or a resveratrol capsule daily for 1 year. The study seeks 60 volunteers with mild-to-moderate Alzheimer's.
    Trial details at ClinicalTrials.gov

  • Semagacestat is a gamma-secretase inhibitor. Gamma-secretase is an enzyme that plays a key role in producing the beta-amyloid that goes on to accumulate in the hallmark plaques of Alzheimer's. Inhibiting gamma-secretase may decrease the production of beta-amyloid and beta-amyloid plaques. Recruitment of 1,500 volunteers with mild to moderate Alzheimer's is under way.
    Trial details at ClinicalTrials.gov

  • Solanezumab is an anti-beta-amyloid antibody designed to bind to and remove the beta-amyloid protein that accumulates in the brains of those with Alzheimer’s. It binds to soluble beta-amyloid and may pull the beta-amyloid away from the brain to be cleared through the blood. Two Phase III studies of Solanezumab are under way that seek a total of 2,000 volunteers with mild-to-moderate Alzheimer’s at more than 50 sites in the United States and Canada.
    Trial details at ClinicalTrials.gov

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