About the Investigational Drug
The FDA-approved medications for Alzheimer's that are currently available are designed to treat the symptoms of Alzheimer's. There are currently no approved medications that treat the disease itself, or its causes.
In contrast, the GAP Study is evaluating an investigational drug to determine if it may help slow the progression of Alzheimer's by acting on some of the disease's underlying causes. Researchers believe that this investigational drug – a form of Intravenous Immune Globulin (IVIg) called Gammaglobulin – may reduce a substance in the brain called amyloid, which builds up abnormally in the brains of people with Alzheimer's disease. It is the build-up of amyloid into plaques that is thought to lead to the development of Alzheimer's.
This investigational drug is made from pooled human plasma, and contains antibodies (proteins) that bind to amyloid – the substance that abnormally accumulates as plaques in the brains of patients with Alzheimer’s disease. Researchers believe that IVIg may aid in the removal of amyloid plaques, or reduce their levels in the brain.
IVIg (intravenous immune globulin) may also be known as "IGIV" (immune globulin intravenous) but generally both terms refer to the same therapy.
IVIg is FDA-approved for other conditions; this study will examine its effectiveness, safety, and tolerability when it is used for Alzheimer's disease. In this study, IVIg will be evaluated alongside standard-of-care medications for Alzheimer's disease – so neither you nor the person in your care will have to stop taking Alzheimer’s medications.
Neither the participant, nor his or her study partner, nor the study doctor will know whether the participant is receiving IVIg or placebo.
