TauvidAlzheimer's disease - diagnosis
Development and Regulatory status
Phase II Clinical Trials
May 20Approved in the US with Priority Review status. Tauvid is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease [1,2].
Radioactive diagnostic agent that binds to tau and amyloid proteins in the brain, recognised hallmarks of Alzheimers disease, allowing imaging with a PET scan to help identify the presence of tau pathology .
More than 520,000 people in the UK have dementia caused by Alzheimers disease and this figure is set to rise .
Alzheimer's disease - diagnosis
Trial or other data
May 20US approval was based on data from two PIII studies: Study 1 (NCT02516046) and Study 2 (NCT03901092). The first study enrolled terminally ill patients (n=156) who agreed to undergo Tauvid imaging and participate in a post-mortem brain donation program. In 64 of the patients who died within 9 months of the Tauvid brain scan, evaluators’ reading of the Tauvid scan was compared to post-mortem readings from independent pathologists who evaluated the density and distribution of NFTs in the same brain. The study showed evaluators reading the Tauvid images had a high probability of correctly evaluating patients with tau pathology and had an average-to-high probability of correctly evaluating patients without tau pathology. The second study included the same patients with terminal illness as the first study, plus 18 additional patients with terminal illness, and 159 patients with cognitive impairment being evaluated for Alzheimer’s disease (the indicated patient population). The study gauged how well Tauvid evaluators’ readings agreed with each other’s assessments of the readings. Perfect reader agreement would be 1, while no reader agreement would be 0. In this study, reader agreement was 0.87 across all 241 patients. In a separate subgroup analysis that included the 82 terminally ill patients diagnosed after death and the 159 patients with cognitive impairment, reader agreement was 0.90 for the patients in the indicated population and 0.82 in the terminally ill patients. Tauvid’s ability to detect tau pathology was assessed in patients with generally severe stages of dementia and may be lower in patients in earlier stages of cognitive decline than in the patients with terminal illness who were studied. The most common adverse reactions in patients using Tauvid were headache, injection site pain and increased blood pressure [1,4].