PD CLINICAL TRIALS
The first ever-clinical trials website dedicated entirely to Parkinson's disease is currently available. The PDtrials site (www.PDtrials.org) is a comprehensive resource for finding and understanding clinical trials in PD. It was developed by the Advancing Parkinson's Therapies (APT) campaign, which is a public awareness endeavor dedicated to accelerating the development of new PD treatments as well as increasing participation in clinical research. PDtrials is co-sponsored by all of the major Parkinson's organizations including the American Parkinson Disease Association (APDA) and is in partnership with the National Institutes of Health. If you do not have computer access, you can call for information toll-free at 1-800-801-9484.
IND is an independent 501(c)3 nonprofit research institute based in New Haven, Connecticut. Its team of expert researchers includes neurologists, nurses, study coordinators, neuropsychologists, and nuclear medicine technologists working together to accomplish IND’s mission. Its team of expert researchers includes neurologists, a nuclear medicine physician, nurses, study coordinators, neuropsychologists, and imaging technologists working together to accomplish IND’s mission.
IND stands as a premier clinical and imaging research facility. A focus of its research is to develop innovative neuroimaging tools to detect neurologic conditions before symptoms appear, make an accurate diagnosis and monitor disease progression. In addition, IND participates in the evaluation of new symptomatic treatments and the development of medications with the potential of slowing disease progression.
To contact IND with any questions about research:
Call: 800-401-6067 or 203-401-4300
FDA Approves Datscan™ (Ioflupane I 123 Injection) For Visualization Of Dopamine Transporters In Patients With Suspected Parkinsonian Syndromes (taken, in part, from Medical News Today, Jan. 15, 2011, www.medicalnewstoday.com)
GE Healthcare announced the US Food and Drug Administration (FDA) has approved DaTscan™ (Ioflupane I 123 Injection), a radiopharmaceutical agent intended for use with single photon emission computed tomography (SPECT) imaging, for the detection of dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes (PS).1 The first FDA-approved diagnostic imaging agent to help physicians evaluate neurodegenerative movement disorders, such as idiopathic (of unknown cause) Parkinson's disease (PD), DaTscan may be used as an adjunct to other diagnostic evaluations to help differentiate essential tremor (an involuntary shaking of the hands, head, and face2) from tremor due to PS. DaTscan cannot differentiate between the different types of PS.
"Ioflupane [DaTscan] may be an important new imaging agent for physicians in differentiating diseases such as Parkinson's disease from Essential Tremor," said Mark Stacy, MD, neurologist and director of the Duke Movement Disorders Clinic at Duke University Medical Center in Durham, NC. "Understanding exactly what you are dealing with is important in selecting the appropriate treatments for patients with movement disorders."
The FDA's action, following a Priority Review, marks the approval of the first radiopharmaceutical agent to detect DaT distribution within the brain (dopamine is a brain chemical that is classified as a neurotransmitter and is found in regions of the brain that regulate activities such as movement and emotion3). Visualization of DaT distribution within the brain may help decrease diagnostic uncertainty in adult patients with suspected PS. The FDA granted DaTscan Priority Review due to an unmet clinical need for an imaging agent to assist physicians in managing patients according to their dopaminergic status. Parkinsonian syndromes are a group of neurodegenerative disorders (including multiple system atrophy, progressive supranuclear palsy and idiopathic Parkinson's disease) characterized by rigidity, tremor and an impaired ability to walk.4
"Currently, movement disorders are diagnosed through clinical examinations, blood tests and neuropsychological evaluations, which are not conclusive and may lead to misdiagnosis," Dr. Stacy said. "A new diagnostic adjunct to existing clinical assessments represents a meaningful contribution to the movement disorders field."
The FDA's approval of DaTscan was based on two Phase 3 clinical trials confirming the efficacy of DaTscan for the visualization of DaT distribution within the striata, an interior part of the brain. These studies, evaluating 284 adult patients with tremor, demonstrated the consistent performance of DaTscan in the visual detection of DaT distribution in the brain when compared with a reference clinical diagnosis.1
"We are confident that DaTscan, an objective and accurate marker of dopamine transporters, will better inform physicians' diagnostic decisions," said Stephen Lightfoot, MI-SPECT Segment Leader, GE Healthcare Medical Diagnostics. "By potentially enabling better disease management, we expect that DaTscan will greatly benefit the patient community."
For more information on medical updates, visit the national APDA's website at www.apdaparkinson.org
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