A progressive neurodegenerative disease, Alzheimer’s (“AD”) currently affects 5.4 million patients in the US alone; it is multifactorial, amyloid hypothesis prevailing, and it is thus a disease mechanism that is only partially understood. This incomplete understanding of AD has resulted in a substantial unmet medical need.
To date, there is a profound lack of effective medications that treat more than merely AD symptoms.
Additionally, there are available only insufficient disease management treatments that combine drug therapies, lifestyle changes, and special diets Alzheimer’s Disease.
These cumbersome treatments present researchers and physicians with difficult diagnostic challenges in part because the disease is commonly detected at the dementia stage.
Further related diagnostic problems include the fact that current diagnostics are time consuming, costly, and often inaccurate.
This situation has led to a significant unmet need for diagnostic tools specific to the pre-dementia stage.
Alzheimer disease is the leading cause of dementia among older people. An estimated 10 percent of Americans over the age of 65 and half of those over age 85 have Alzheimer's. More than five million Americans currently suffer from the disease, and the number is projected to balloon to 10-15 million over the next several decades. Alzheimer's is now the third most expensive disease to treat in the U.S., costing society close to $100 billion annually.
In the popular imagination, Alzheimer disease is equated with an impaired memory, but the disease includes a number of other changes in brain function that result in inattention, disoriented behavior, altered personality, difficulty speaking and comprehending, and impaired gait and movement.
Alzheimer's is a progressive, incurable disease. The earliest damage occurs in the entorhinal cortex, hippocampus and basal forebrain, which are small, specialized structures in the brain that play a critical role in memory. The disease is characterized by amyloid plaques (deposits in the brain of a sticky protein called amyloid beta peptide) and neurofibrillary tangles (abnormally twisted forms of the protein tau, in the long branches of neurons). The cause remains a mystery.
Over time, the disease destroys large areas of the brain, leaving its victims with little comprehension or awareness. As the disease advances, patients become incontinent, bedridden and unable to feed themselves. From the onset of symptoms, the disease runs its course in from two to 15 years. Seven years is the average extent, but patients may survive as long as 20 years. Alzheimer's always ends in death, typically from pneumonia or lack of nutrition.
National Institute on Aging: Booklet: Preventing Alzheimer’s Disease, What Do We Know?