Alzheimer’s disease (AD), a type of dementia that affects memory, thinking, and behavior, accounts for 60-80% of dementia cases and is not considered a normal aspect of aging. Unfortunately, current diagnostic techniques are inaccurate, time-consuming, and drain financial resources. As new treatments for AD emerge, the need for a simple, definitive way to distinguish AD from other neurodegenerative conditions has gained urgency in the past few years.
The most promising breakthrough for identifying AD is an autopsy-confirmed, minimally invasive skin test to support clinicians’ definitive diagnosis of AD vs. other forms of dementia. This test has the potential to help patients and families get on the right treatment path for improved quality of life.
Impact of AD
An estimated 5.8 million Americans aged 65 and older are living with AD. In 2020, AD and other dementias cost the nation $305 billion, including $206 billion in Medicare and Medicaid payments.
The majority of people with AD are 65 and older, with symptoms growing worse over a number of years. In the early stages of AD, memory loss is mild but gradually individuals lose the ability to respond to their environment. Typically, AD patients live four to eight years after diagnosis but can live as long as 20 years, depending on other factors. Disease
Value of Early AD Diagnosis
An early diagnosis of AD can help determine if a patient’s symptoms are truly due to AD or some other condition that can be curable, such as infections, emotional distress, or nutritional deficiencies, such as a vitamin B12 deficiency. Disease
One-in-three patients with memory issues do not have AD and can benefit from treatment that’s more appropriate based on the cause of their dementia. For AD patients, no drug, including the one recently approved by the FDA, can treat the underlying disease.
Studies indicate that 54% of people living with AD also have dementia attributable to other conditions, or mixed dementia. Until now, only autopsy studies have been definitive to identify mixed dementia as current tests don’t adequately measure most dementia-related brain changes in living people. Having an accurate diagnosis of AD in people living with mixed dementia can improve care plans and therapeutic interventions. Disease
An early diagnosis allows patients to start clinical interventions sooner, providing cost savings for payers, as well as saving time, money, and the despair of not knowing for those involved. Early diagnosis also gives patients and/or their families the chance to have a say in their own care. Disease
How AD Test Works
The new AD test – which relies on assays that have demonstrated >95% sensitivity and specificity—assesses factors directly related to the formation of synaptic connections in the brain, impacting loss of memory and cognition in people living with AD. Synaptic connections allow the brain’s nerve cells to communicate with each other. It also identifies the AD-specific degeneration for a definitive diagnosis even in the presence of other co-existing degenerative disorders.
This new AD test should be considered a tool to manage appropriate patient access to future approved therapies, in addition to the clinical and economic benefits of improved early, accurate diagnosis. Disease
Key factors to look for in an AD test include:
- Accurate diagnosis of AD through a minimally invasive procedure in the clinician’s office
- Accurately assess several critical factors directly related to AD that regulate memory, the presence of functional synaptic connections among neurons, the level of amyloid plaques, and the level of neurofibrillary tangles in the brain.
- Accuracy identifying AD earlier in people diagnosed with dementia. Developed by testing and following patients with dementia over several years prior to death, establishing plaque and tau at autopsy, which is validated against the NIH gold standard
- Awarded reimbursement codes and a payment amount set by the Centers for Medicare & Medicaid
- Demonstrates high specificity and sensitivity >95% in both early and late-stage AD and distinguishing AD in people living with mixed dementia.
Giving providers, patients and their families a clear answer about AD helps them focus on the patient journey enables pharmaceutical companies to identify appropriate clinical trial participants and allows accredited sources of reimbursement to establish protocols and prior authorizations for prescribing and reimbursing treatment. Disease
Author: Dr. Daniel Alkon, Chief Scientific Advisor, SYNAPS Dx