Enabling nationwide AD PET imaging to support most efficient clinical trials by adoption of radically simplified and standardized quality control in commercial production of AD PET tracers.

Positron Emission Tomography (PET) is the most powerful imaging procedure relied upon in the management of

Alzheimer’s Disease (AD). It provides information on the molecular processes in the brain. PET imaging studies require

short-lived radioactive contrast agents called PET tracers. Multiple PET tracers have a strong predictive value in AD.

The long-term objective of the proposed work is availability of AD PET imaging to broad AD population, which

enables (1) detection of disease in pre-symptomatic stage and (2) most effective clinical trials for development of AD

therapies. Both of these impacts lead to improved outcomes for AD patients. Thereby, this project is considered highly

relevant to the mission of National Institute on Aging (NIA).

Trace-Ability plans to enable nationwide availability of AD PET imaging by eliminating production complexity rooted

in release testing of AD PET imaging tracers. The enabling solution will be demonstrated with of [F-18]Flortaucipir

(leading tau PET tracer with pending NDA) and [F-18]Florbetaben (FDA-approved Beta Amyloid PET tracer), thereby

demonstrating solution’s universal applicability to multiple AD PET products.

Proposed solution relies on complete automation of release testing on Tracer-QC platform that has been validated

earlier with the most common PET tracer, F 18 Fludeoxyglucose (FDG) and demonstrated with [F-18]Florbetaben.

Current experience has identified critical gaps that need to be filled in order to achieve broad commercial adoption of

these products. By filling these gaps with R&D focused on 2 specific aims, proposed Direct to Phase II project enables

rapid expansion of AD PET imaging to the broad AD population.

Specific Aim 1: Achieve overall solution reliability required for broad commercial deployment by demonstrating

failure of