There is an unmet medical need for a new therapeutic option in Alzheimer’s Disease (AD).
Photograph of the same individual progressing through various stages of Alzheimer disease. These pictures were taken just 16 months apart. He passed at 74 years of age.
Several prescription drugs are currently approved by the U.S. Food and Drug Administration (US FDA) to treat symptoms of mild to moderate Alzheimer’s disease. Treating the symptoms alone can provide comfort, dignity, and independence for a period of time and can also give hope to both caregivers and families.
Almost all drugs used to treat the symptoms of AD are cholinesterase inhibitors. However, these treatment options may have horrible side effects that make using them, at the effective dose, challenging for both patients and caregivers. As a result of these side effects, many patients simply can’t tolerate the efficacious dose and settle on a less effective dosing regimen or stop therapy. These medications are given as oral tablets or capsules and prescribed routinely for mild to moderate Alzheimer’s disease. Clinical studies have shown them to be effective in reducing symptoms and helping to control some common behavioral problems. Sadly, all of the drugs in this class may cause side effects that include nausea, vomiting, diarrhea and, in the worst cases, dizziness, sleep issues, loss of appetite, and weight loss. While the positive effect of these drugs may compensate somewhat for the side effects, they often have a negative impact on the quality of life of these patients and, most importantly, may deter many patients from taking the appropriate dose of the drug, and that may reduce or even eliminate any of the benefits seen had higher doses been tolerated.
Over the years, evaluations of patients able to tolerate cholinesterase inhibitors at high doses have noted a measurable delay in the progression of the disease’s symptoms and in the time a patient may avoid being institutionalized. In one such study where patients taking effective doses of galantamine (Razedyne®) were followed, a notable delay, possibly as long as 2 years in their progression toward full time care was observed.
The chart below illustrates this clearly Galantamine’s delay in Nursing home care