Alzheimer’s Disease Mild-to-Moderate Stage & Moderate-to-Severe Market:
An estimated 6.9 million Americans age 65 and older are living with Alzheimer’s dementia in 2023(1). This often causes burdensome effects on their families and caregivers. It is by far the most common form of dementia, estimated to be 60% to 80% of all diagnosed cases(1). Treatment options for Alzheimer’s Disease are limited, and health care professionals along with patients/caregivers are generally dissatisfied with the currently available treatments due to limited efficacy and unmanageable tolerability from adverse events.
Of the patients with Alzheimer’s Disease, the vast majority, approximately 2.5 million(1), have been diagnosed with mild Alzheimer’s Disease. Mild Alzheimer’s Disease is expected to grow over the next decade, signaling a continued need for symptomatic drugs with greater efficacy and fewer side effects.
Current acetylcholinesterase inhibitor medications are absorbed in the gastrointestinal system and bind to locally present acetylcholinesterase, the enzyme responsible for breaking down the neurotransmitter, acetylcholine. The local acetylcholine levels are then increased, and the neurons associated with the gastrointestinal system become overstimulated. The result is an increase of gastrointestinal side effects (nausea, vomiting, diarrhea).
Alzheimer’s disease symptomatic treatments are currently limited and perceived to provide limited symptom improvement and cause difficult to manage tolerability side effects. Symptomatic treatments are designed to improve the ability to learn, remember data, and function normally with daily tasks like toileting, cooking, or home care. Each year more than 2 million patients are on medication for the disease, which makes up half of the estimated number of people with Alzheimer’s disease in the US. Approximately 70% of patients with mild Alzheimer’s disease, 80% with moderate, and 75% with severe Alzheimer’s disease are on drug-treatment. On average, it can take up to 2.5 months from diagnosis to treatment, but can take up to 2 years, and roughly 32% will never go on treatment. Patients are treated primarily with symptomatic medications to help the cognitive and functional symptoms of Alzheimer’s disease. In addition to symptomatic treatments, patients will also be prescribed behavioral and psychiatric medications for depression, hallucinations, aggression and agitation.
Alzheimer’s Disease Moderate-to-Severe Stage Market:
Of the approximately 3.9 million people that have been diagnosed with Alzheimer’s Disease, the moderate-to-severe market size is approximately 1.4 million people in the U.S. (moderate Alzheimer’s Disease accounts for approximately 899 thousand patients and severe Alzheimer’s Disease affects approximately 508 thousand patients). In the moderate stage of Alzheimer’s Disease symptoms becomes more intense, significantly affecting their everyday life. They have difficulties with communication and personality and behavioral changes present. It’s estimated that 61% of Alzheimer’s Disease patients living in a nursing home are in the moderate to severe stages of the disease. On average, 40% of the final years of an Alzheimer’s Disease patient’s life will be spent in the severe stage of the disease and majority will have to be place in a long-term care home due to the immense burden this stage places on family members and caregivers. According to third-party market research reviewed by the Company, the Company understands that many providers and caregivers believe the approved generic medications provide limited efficacy and adverse effects.
(1) Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2023;19(4). DOI 10.1002/alz.13016.