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Data from a pooled analysis of four clinical trials, presented today at the American Academy of Neurology’s 66
th Annual Meeting in Philadelphia, showed that using DaTscan™ (Ioflupane I 123 Injection) with single-photon emission computed tomography (SPECT) brain imaging was associated with a high level of diagnostic effectiveness.
The analysis showed high overall sensitivity and specificity of DaTscan images to detect a striatal dopaminergic deficit, which is associated with several conditions, including Parkinsonian syndromes (PS). Across all four studies, when images were assessed by on-site readers, the overall sensitivity was 91.9% and specificity was 83.6%. When images were assessed blindly by a panel of independent experts, the overall sensitivity was 88.7% and specificity was 91.2%.
DaTscan is a radiopharmaceutical approved in the United States for striatal dopamine transporter visualization, using SPECT brain imaging to assist in the evaluation of adult patients with suspected PS to help differentiate PS from essential tremor (ET). In Europe, where DaTscan is marketed as DaTSCAN, it is indicated for detecting loss of functional dopaminergic neuron terminals in the striata of adult patients with clinically uncertain PS to help differentiate PS from ET, or to help differentiate probable dementia with Lewy bodies (DLB) from Alzheimer’s disease. DaTscan (DaTSCAN in the EU) are adjuncts to other diagnostic evaluations. In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions, and injection site pain have been reported.
The results of this pooled analysis were presented by Dr. Grosset during Session S8: Aging, Dementia, and Cognitive and Behavioral Neurology: PET Imaging on Tuesday, April 29, at 1:45 PM. The study was sponsored by GE Healthcare.
A Commitment to Understanding Neurodegenerative Disease
GE Healthcare takes a comprehensive approach to understanding a variety of neurological disorders, such as Alzheimer’s disease, Parkinson’s disease, posttraumatic stress disorder, concussion, traumatic brain injury, and multiple sclerosis, through its ongoing research to uncover the causes, risks, and physical effects of these conditions. By collaborating with the pharmaceutical industry to assist in the development of the next generation of therapies to treat these disorders and working with potential partners in the industry, GE Healthcare can provide imaging support for clinical trials of therapeutic agents.