Molecular Imaging Program
ALTROPANEŽ - PD
Parkinson's Disease (PD) is a neurodegenerative movement disorder characterized by the loss of dopamine-producing neurons in the brain. This process begins long before symptoms of the disease actually begin. Symptoms of PD are often similar to many other movement disorders. Consequently, misdiagnosis rates are high, with peer-reviewed literature reporting up to 50% misdiagnosis in the early stages. In the U.S., there is currently no available test that can clearly identify Parkinson's Disease, especially in early cases.
Diagnostic Approach
Alseres Pharmaceuticals is developing ALTROPANE, a 123I-labeled small molecule with high selectivity for the Dopamine Transporter (DAT), as an aid in the diagnosis of PD. ALTROPANE's molecular imaging agent uses Single Photon Emission Computed Tomography (SPECT)technology to rapidly and selectively visualize DATs located on the dopamine-producing neurons in the brain. A SPECT scan using ALTROPANE visibly displays DATs on the surface of the dopamine neurons providing insight into the number of DATs present. A low signal with ALTROPANE suggests low DAT levels and therefore low numbers of dopamine-producing neurons, a hallmark of PD. Our clinical studies are designed to demonstrate that SPECT scans of individuals with Parkinson's Disease show a marked decrease in the binding of ALTROPANE (indicating a loss of dopamine-producing neurons) when compared with individuals without loss of these neurons.
Normal human SPECT brain scan using ALTROPANE®
Image Source: Boston University Medical Center
Human Parkinson's Disease SPECT brain scan using ALTROPANE®
Image Source: Hospital of the University of Pennsylvania
Development
Five clinical studies testing nearly 500 individuals have been completed using ALTROPANE as a molecular imaging agent. Results from the completed studies-including a Phase III trial designed to confirm the utility of ALTROPANE imaging to differentiate Parkinsonian Syndrome (PS) movement disorder from non-PS movement disorders-met their endpoints with statistical significance.
In March 2006, we concluded the Phase III trial known as "Parkinson's or Essential Tremor" (POET-1), the first of two expected Phase III clinical trials. The goal of POET -1 was to assess whether ALTROPANE imaging is more effective than the subjective methods used by general practitioners (GP) to distinguish between tremors caused by Parkinsonian Syndrome and those associated with other disorders.
In September 2006, we announced the results of the Phase III POET-1 clinical trial. The results demonstrate that the diagnosis from ALTROPANE scans had statistically significant superiority over the diagnosis of GPs on measures of both specificity and sensitivity. Alseres expects to begin the Phase III, POET-2 program in 4Q, 2007.
For a list of websites providing information on Parkinson's Disease, click here.