New data show benefit of DaTSCAN™ (Ioflupane I 123 Injection) in the diagnosis of patients with clinically uncertain dementia with Lewy bodies

Date: Oct-01-2013Data presented at the XXI World Congress of Neurology in Vienna suggest that DaTSCAN™ (Ioflupane I 123 Injection) SPECT imaging could add value to current diagnostic tools used by physicians to diagnose patients with dementia with Lewy bodies (DLB) by improving physician's ability to definitively diagnose the disorder and increase their confidence in so doing. DaTSCAN is GE Healthcare's radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging.

Data presented in two abstracts from a multicenter (21 centers in 6 European countries), randomized, open-label, comparative clinical trial evaluated the impact of DaTSCAN SPECT imaging on the clinical diagnosis of dementia and physician confidence of that diagnosis in patients with possible DLB who underwent DaTSCAN imaging (N=114) compared with those in the control group who did not (N=56). Specifically:
A higher proportion of patients who underwent DaTSCAN SPECT imaging had a change in diagnostic category after 8 weeks (61% vs 4%; P
In subjects with possible DLB who did not receive imaging, the clinical evolution of symptoms over 6-months did not impact the diagnosis. However, the result of a DaTSCAN image, in combination with the clinical features, contributed significantly to a change in dementia diagnostic category.[ii]

"The diagnosis of a patient with DLB can be challenging, particularly in patients with clinically uncertain DLB," said Igor Grachev, MD, Medical Director, GE Healthcare Life Sciences. "While the diagnosis often becomes clearer over time, particularly as signs and symptoms progress, in many cases true DLB can be missed. This study shows that DaTSCAN SPECT imaging, when used in combination with other core and suggestive features, has the ability to facilitate a more certain confident diagnosis."

DLB is one of the most common types of degenerative dementia, and is a common form of dementia in old age, accounting for nearly 15-20 percent of cases.[iii] The central feature of DLB is progressive cognitive decline, combined with three additional defining features: (1) pronounced "fluctuations" in alertness and attention, such as frequent drowsiness, lethargy, lengthy periods of time spent staring into space, or disorganized speech; (2) recurrent visual hallucinations, and (3) parkinsonian motor symptoms, such as rigidity and the loss of spontaneous movement.[iv]
About DaTSCAN™ (Ioflupane I 123 Injection)

DaTSCAN is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging. DaTSCAN works by binding to dopamine transporters (DaT) in the brain. A specific marker for DaT, DaTSCAN produces images that provide visual evidence based on the density of dopamine transporters.

In July 2000, the European Commission granted a Marketing Authorization under the trade name DaTSCAN for use in detecting loss of functional dopaminergic neurons (nerve cells in the brain) in patients with clinically uncertain Parkinsonian syndrome (PS). In July 2006, the European indication was expanded to include differentiation of probable DLB from Alzheimer's Disease (AD). DaTSCAN is currently licensed and distributed in 34 countries, and has been in clinical use for ten years in more than 300,000 patients worldwide.
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