SAAmplify-ɑSYN Biomarker Test for Lewy Body Dementia and Other Dementias

What is the SAAmplify-ɑSYN Biomarker Test for Brain Diseases?

The SAAmplify-ɑSYN biomarker test, formerly known as the SYNTap test, is used to differentiate between types of dementia, specifically  those at risk of Parkinson’s disease and Lewy Body dementia. When the SYNTap test was first introduced, it was considered a game changer for treating dementia, as there was previously no reliable method for differentiating between Lewy Body dementia and other dementias including Alzheimer’s disease. Mayo Clinic Laboratories and Amprion began collaborating in March 2025 as producers and distributors of the SAAmplify-ɑSYN test.

Telling the difference is important, because treatments and therapies can be successful for slowing down the progression of dementia if a correct diagnosis is made.

For those at risk of Lewy Body dementia or Parkinson’s because of genetic or family histories, SAAmplify-ɑSYN can detect the presence of protein tangles that cause those diseases years before symptoms occur, and early diagnosis is important for managing symptoms and improving one’s quality of life.

Symptoms of Lewy Body dementia are somewhat different than Alzheimer’s disease. With LBD, there are moment-to-moment fluctuations in memory and alertness, and hallucinations and delusions are more common. For more on Lewy Body dementia, including subtypes, symptoms, and treatments, click here.

How Does the SYNTap Test Work?

The SAAmplify-ɑSYN is a biomarker test for detecting Lewy Bodies in spinal fluid. Lewy Bodies are clumps or misfolds of alpha-synuclein proteins which have been found (during autopsies after death) in the brains of people with Lewy Body dementia, Parkinson’s, Multiple System Atrophy, and other brain diseases.

The process for taking the SAAmplify-ɑSYN test is that a medical professional removes, via spinal tap or lumbar puncture, a few drops of cerebrospinal fluid and sends them to Amprion’s laboratory. In the lab, Lewy Bodies can be identified using a fluorescent probe. Results are reported back to the patient’s doctor in about two weeks.

A negative SAAmplify-ɑSYN test means the disease-causing protein folds (Lewy Bodies) have not been detected in an individual, while a positive test indicates they are present. Someone who receives a positive test would then work with medical specialists on treatment including medication and therapies to slow the progression of symptoms and maintain high quality of life for as long as possible.

Anyone who wants a SAAmplify-ɑSYN test should talk to their doctor, or order a test online.

Why Differentiating Between Lewy Body Dementia and Other Brain Diseases is Important

Lewy Body dementia has symptoms similar to other diseases, including Alzheimer’s disease, and because of this it is often misdiagnosed. For someone with LBD, an accurate diagnosis is important because certain medications that would normally be prescribed to help symptoms of Alzheimer’s disease, like anticholinergics, can actually be harmful to someone with LBD.

Further, caregivers and loved ones will want to be as familiar as possible with the disease so they can better understand symptoms and how to interact. Someone with LBD, for example, will have larger mood swings from day to day. And the home will need to be made safer sooner for someone with LBD, as balance is typically worse than with other forms of dementia. (See more on Home Safety Measures for persons with dementia.)

LBD or Parkinson’s?

The same alpha-synuclein tangles detected by the SAAmplify-ɑSYN test are present in both Lewy Body dementia and Parkinson’s disease. The way to tell the difference after a positive test is via symptoms:

• Parkinson’s disease: Someone with movement or functional symptoms only is likely to be diagnosed with Parkinson’s.
• Lewy Body dementia: Mental (cognitive) symptoms like memory loss and/or hallucinations make a diagnosis of LBD likely.

Who Should Take the SAAmplify-ɑSYN test?

The SAAmplify-ɑSYN test is designed to test individuals who have either of these considerations:

• Symptoms of brain disease, both in thinking ability and motor functions
• Higher risk due to genetics or family history of Parkinson’s disease or Lewy Body dementia

Someone showing symptoms of Alzheimer’s disease, usually beginning with memory loss (click here for a full list) would want to take a SAAmplify-ɑSYN test to help determine whether they have Alzheimer’s, Lewy Body dementia, a mixed dementia or another type of brain disease.

The SAAmplify-ɑSYN Test for People with Alzheimer’s Disease

Someone with confirmed Alzheimer’s disease might also consider taking the SAAmplify-ɑSYN test, because about 40% of brains with Alzheimer’s have shown the alpha-synuclein protein tangles the test detects. If these protein tangles are present, it may affect how the Alzheimer’s disease progresses and which treatments are best for managing symptoms.

How Much Does the SAAmplify-ɑSYN Test Cost and Insurance Coverage?

The cost of a SAAmplify-ɑSYN test is $1,500 for the lab test. The company Amprion is working with private insurance companies and Medicare and Medicaid to get the cost of the test covered, so someone who takes the test would not need to pay out-of-pocket. Until then, the company sends a bill to the patient after the lab runs its SYNTap test.

Is the SAAmplify-ɑSYN Test FDA Approved?

Despite the SAAmplify-ɑSYN Tests availibility in most states, it has not yet received full approval from the Food and Drug Administration, but the FDA did give Amprion a “Breakthrough Device” designation as a review continues. This means the test is considered effective for making diagnoses, and there is not a viable alternative. Amprion is in the process of seeking full FDA approval, which would make it more likely to be covered by insurance.