DaTSCAN™ (Ioflupane I 123 Injection) SPECT Imaging Demonstrates Impact on the Diagnosis of Patients with Clinically Uncertain Dementia with Lewy Bodies

Thu Mar 21, 2013 5:00am EDT

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New data on physician`s confidence in diagnosis following use of DaTSCAN
presented at 2013 American Academy of Neurology Meeting
CHALFONT ST. GILES, England--(Business Wire)--
GE Healthcare today presented the results of a randomized study analyzing the
effect of DaTSCAN (Ioflupane I 123 Injection) SPECT imaging in a group of adult
patients with a diagnosis of possible dementia with Lewy bodies (DLB). The
findings, presented at the 2013 American Academy of Neurology Meeting, reported
use of DaTSCAN imaging significantly contributed to a change in diagnostic
category and improved physician confidence in diagnosing these patients.1

"A clinical diagnosis of DLB can be particularly challenging, and this study
reported that the use of DaTSCAN SPECT imaging in patients with possible DLB
resulted in more changes from baseline diagnosis than in patients evaluated
based only on clinical examination and routine investigations," said Zuzana
Walker, MD Reader in Psychiatry of the Elderly, UCL Mental Health Sciences Unit,
University College of London, and lead author of the study. "In addition, in
this study, physicians who had access to DaTSCAN imaging for their patients
reported greater confidence in their diagnoses, which may enable them to make
more appropriate treatment decisions and provide better support and advice to
their patients." 

This multicenter (23 centers in 6 European countries), randomized, open-label,
comparative clinical trial evaluated the impact of DaTSCAN SPECT imaging on
diagnosis and on the diagnostic confidence of clinicians in patients diagnosed
with possible DLB who underwent DaTSCAN imaging (N=114) with those in the
control group who did not (N=56). The proportion of patients with changes in
clinical diagnosis and changes in confidence in diagnosis from baseline was
compared between the two groups at 8 and 24 weeks from baseline. 

Results showed that significantly more patients in the DaTSCAN imaging group had
a change in diagnostic category compared to patients in the control group after
8 weeks (61% versus 4%, P<.0001) and after 24 weeks (69% versus 16%, P<.0001).
Additionally, physicians with access to DaTSCAN imaging for their patients
reported significantly more confidence in their diagnoses at 8 and 24 weeks of
follow-up (p < 0.0001) compared with physicians of control patients. Clinicians
reported that they were more likely to change the diagnostic category if the
DaTSCAN image was abnormal (82%) than if the result was normal (48%). 

Dementia with Lewy bodies (DLB) is one of the most common types of progressive
dementia, and is a common form of dementia in old age, accounting for nearly
15-20 percent of cases.2 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. 3

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 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. 

To learn more about DaTSCAN, visit www.DaTSCAN.com. 


DaTSCAN is one component of a broad portfolio of marketed and investigational
diagnostic solutions that GE Healthcare is currently developing in the
neurological disease field. GE Healthcare takes a comprehensive approach to
understanding a variety of neurological disorders such as Alzheimer`s disease,
Parkinson`s disease, post-traumatic 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 their 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. 

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to
meet the demand for increased access, enhanced quality and more affordable
healthcare around the world. GE (NYSE: GE) works on things that matter - great
people and technologies taking on tough challenges. From medical imaging,
software & IT, patient monitoring and diagnostics to drug discovery,
biopharmaceutical manufacturing technologies and performance improvement
solutions, GE Healthcare helps medical professionals deliver great healthcare to
their patients. 

For more information about GE Healthcare, visit our web site at
www.gehealthcare.com. For our latest news, please visit

1 Walker Z, et al. A multicenter, randomized, open-label, comparative phase 4
trial to assess changes in dementia diagnostic category and diagnostic
confidence after DaTSCAN imaging in subjects with an uncertain diagnosis of
dementia with Lewy bodies (possible DLB). Poster presented at 2013 American
Academy of Neurology Meeting. 

2 McKeith IG. Dementia with lewy bodies. British Journal of Psychiatry 2002.

3 NINDS Dementia With Lewy Bodies Information Page. Accessed 3/11/2013 at:

GE Healthcare
Scott Lerman
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+1 609 937 9253 (mobile)

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