A CSF/blood plasma test detecting and quantifying pathologic TDP-43 for FTLD-TDP by ELISA as either a diagnostic tool for suspected FTD cases or prognostic indicator.

Despite intense research, there remains a high unmet medical need for a clinically meaningful diagnostic and disease-modifying therapeutics in the FTD space.

Frontotemporal dementia (FTD) is a heterogeneous neurodegenerative disease characterized by progressive behavior and/or language impairments that include various clinical subtypes. FTD is the second most common neurodegenerative disorder in people under 65 and is the most common dementia in those under 60. In patients with FTLD-TDP, TDP-43 changes conformation misfolds and accumulates in intranuclear and cytoplasmic aggregates. These aggregates cause loss of physiological nuclear TDP-43 function as well as induce cellular toxicity. A panel of monoclonal antibodies (mAbs) against the N-terminus or C-terminal domain of TDP-43 have been produced to be highly sensitive and specific for the pathologic forms of TDP-43. An ELISA for detecting brain-derived pathologic TDP-43 and limiting the contribution of normal TDP-43 signals is being validated. Initial ELISA data is establishing the disease-specific antibodies are able to differentiate the molecular composition of FTLD-TDP, FTLD-Tau and Alzheimer's Disease.

Pre-Clinical Validation

• First plasma biomarker for TDP-43 proteinopathy and FTD
• Screening blood plasma samples more straightforward
• Highly sensitive and specific for pathologic TDP-43
• Cost-effective, efficient, and sufficient for world-wide laboratory distribution

Pathologic TDP-43 as a biomarker for the diagnosis of TDP-43 proteinopathy - https://patents.google.com/patent/US20230107901A1/

Alzheimer's Drug Discovery Foundation Funding - https://www.alzdiscovery.org/research-and-grants/portfolio-details/21428391

Aaron Duffy
(801) 585-1377
aaron.duffy@utah.edu