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The purpose of this study is to investigate the utility of dopamine transporter imaging in monitoring and predicting the progression of Parkinson disease. This study will be performed in the PRECEPT cohort, an already existing cohort of 806 subjects recruited to participate in the study called, A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Early Parkinson’s Disease - (PRECEPT), sponsored by Cephalon and Lundbeck and coordinated by the Parkinson Study Group. The imaging data from this long-term PRECEPT follow-up study will allow us to evaluate the long-term progression of DAT loss in PD, the long-term follow-up of SWEDD subjects, the relationship between long-term clinical and imaging PD outcomes, and the relationship between long-term imaging outcomes and genetic and biochemical biomarkers of PD progression.
The 800 early PD subjects in this study have already been evaluated clinically and have undergone longitudinal dopamine transporter (DAT) imaging with [123I] ß-CIT (baseline and 22 months). In Follow-up imaging will be performed at 24-month intervals (46 and 70 months following PRECEPT baseline). All scanning procedures will be performed at the Institute for Neurodegenerative Disorders (IND) using methods previously employed in the PRECEPT study.
Subjects willing to participate will travel to New Haven for their 46-month imaging visit. At IND a study coordinator and a neurologist will evaluate all subjects. The coordinator and neurologist will discuss the study procedures and evaluate the patient for eligibility. Written informed consent for the study will be obtained prior to performing any study-related procedures.
If eligible, participants will be injected with ß-CIT and 24 hours later an imaging procedure will be used to obtain pictures of brain activity using single photon emission computed tomography (SPECT). This 2-day procedure will be repeated at 70 months (following PRECEPT baseline).
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
B-CIT injection and SPECT scanning
Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
Published on BioPortfolio: 2014-08-27T03:41:25-0400
The investigators aim to study whether the nuclear medicine method FP-CIT-SPECT (more details see below) allows to predict the further clinical course of Parkinson´s disease. Especially t...
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This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in resear...
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This work aimed to assess the potential of a set of features extracted from [123I]FP-CIT SPECT brain images to be used in the computer-aided "in vivo" confirmation of dopaminergic degeneration and the...
I-FP-CIT andF-FP-CIT are radiotracers which are widely used to diagnose Parkinson's disease (PD). However, to our knowledge, no studies to date have made head-to-head comparisons betweenI-FP-CIT andF-...
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To investigate whether diabetes mellitus is associated with Parkinson-like pathology in people without Parkinson disease and to evaluate the effect of diabetes mellitus on markers of Parkinson patholo...
Dopamine transporter (DAT) single-photon emission computed tomography (SPECT) is an accurate adjunct to clinical evaluation for Parkinson's disease (PD) in cases where the diagnosis is difficult. Dopa...
Proteins associated with sporadic or familial cases of PARKINSON DISEASE.
A condition caused by the neurotoxin MPTP which causes selective destruction of nigrostriatal dopaminergic neurons. Clinical features include irreversible parkinsonian signs including rigidity and bradykinesia (PARKINSON DISEASE, SECONDARY). MPTP toxicity is also used as an animal model for the study of PARKINSON DISEASE. (Adams et al., Principles of Neurology, 6th ed, p1072; Neurology 1986 Feb;36(2):250-8)
A scanning probe microscopy technique that uses an ultramicroelectrode as the scanning probe that simultaneously records changes in electrochemical potential as it scans thereby creating topographical images with localized electrochemical information.
A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA.
Parkinsonism following encephalitis, historically seen as a sequella of encephalitis lethargica (Von Economo Encephalitis). The early age of onset, the rapid progression of symptoms followed by stabilization, and the presence of a variety of other neurological disorders (e.g., sociopathic behavior; TICS; MUSCLE SPASMS; oculogyric crises; hyperphagia; and bizarre movements) distinguish this condition from primary PARKINSON DISEASE. Pathologic features include neuronal loss and gliosis concentrated in the MESENCEPHALON; SUBTHALAMUS; and HYPOTHALAMUS. (From Adams et al., Principles of Neurology, 6th ed, p754)
Neurology - Central Nervous System (CNS)
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