The U.S. is a rapidly aging nation with 60 million people aged 65 and older. Of these, about 12 million people show early symptoms of Mild Cognitive Impairment. One in three of these people will progress to clinical Alzheimer’s disease (AD) within five years.
New research studies reveal the complexity of AD, from classical Alzheimer’s to mixed-type such as Alzheimer’s with Lewy Bodies. Early detection of AD sub-types helps accelerate treatment innovations to unlock personalized medicine for Alzheimer’s.
Traditionally, Alzheimer’s has been characterized by the presence of two misfolded proteins: Abeta—producing plaques and Tau—forming tangles.
Recent studies discovered a third misfolded protein, alpha-Synuclein (α-Synuclein), co-existing with Abeta and Tau to form a new variant—Alzheimer’s with Lewy Bodies. Research showed that up to 40% of deceased Alzheimer’s patients had Lewy Bodies in their brains. The new finding was discovered through autopsy, the only method currently used to detect Lewy Bodies.
“This insight elevates our understanding of Alzheimer’s as medical science strives to find cures for neurodegenerative diseases,” said Claudio Soto, Ph.D., Amprion co-founder, and chief scientific officer. Patients having AD with Lewy Bodies tend to progress faster than those with classical AD. In addition, these patients show overlapping symptoms of Lewy Body Dementia and Parkinson’s disease. “Since AD with Lewy Bodies requires different treatments, it is critical to distinguish it early. Therefore, we’re bringing to market the SYNTap® Biomarker Test, which accurately detects misfolded α-Synuclein, to help differentiate this AD sub-type early,” added Dr. Soto.
Awarded Breakthrough Device Designation by the U.S. FDA, Amprion’s SYNTap Test is performed in its top-of-the-class CLIA and CAP-accredited clinical laboratory in San Diego.
In a joint study with the Oregon Health & Science University, Amprion conducted a blinded analysis using CSF samples. During clinical test development, the SYNTap Test accurately predicted the presence of Lewy Bodies confirmed at later autopsy. CSF samples were collected 1-15 years before autopsy from patients clinically diagnosed with AD (n=43), some other non-synucleinopathy neurodegenerative disease (n=12), and healthy control subjects (n=4).
Notably, the SYNTap Test detected the presence of misfolded α-Synuclein in CSF from a clinically diagnosed AD patient 10 years before the autopsy identified the presence of Lewy Bodies.
Similar results were observed in a confirmatory study performed with the University of California, San Diego using CSF collected before autopsy (n=64) and CSF collected postmortem (n=32). None of the CSF samples from 36 patients with no brain Lewy Bodies at autopsy tested positive. During our clinical validation, the SYNTap Test detected the presence of misfolded α-Synuclein aggregates, the key component of Lewy Bodies, with a sensitivity of 87.3% and a specificity of 97.2%.
Amprion CEO and Co-Founder Russ Lebovitz, M.D./Ph.D. expressed, “We are thrilled that for the first time in history, the SYNTap Test enables physicians to distinguish Alzheimer’s with Lewy Bodies early—during patients’ lifetimes. The advent of molecular diagnostics will accelerate innovations in therapeutics and personalized medicine for neurodegenerative diseases.”
Team Amprion is looking forward to announcing more insightful research findings as we launch various clinical initiatives in the Alzheimer’s, Parkinson’s, and Lewy Body Dementia (or Dementia with Lewy Bodies) spaces.
Download the SYNTap Test specification sheet to learn more about its performance characteristics.
Gearing Up For More Breakthroughs In 2022
We look forward to making even more impactful discoveries in the New Year! Our top priorities include obtaining FDA approval for the SYNTap Test and expanding rollout into other countries. On the drug R&D front, Amprion is actively exploring strategic BioPharma partnerships to advance biomarker-targeted drugs and therapeutics for brain health.