Parkinsonian Syndrome Clinical Trial
Official title:
Development of a Imaging Marker for Parkinson's Disease Through Use of Dynamic SPECT Imaging With [123I] Beta-CIT in Individuals With Parkinson's Symptoms
The overall goal of this study is to evaluate the use of dopamine transporter (DAT) imaging as a diagnostic tool in subjects with early parkinsonian symptoms, in whom Parkinson's disease (PD) or parkinsonian syndrome (PS) is suspected, but the diagnosis remains unclear from a clinical standpoint.
Status | Completed |
Enrollment | 169 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Age >21 - Any parkinsonian or extrapyramidal symptoms - Parkinsonian symptoms for < 2 years duration. - No significant abnormalities on screening laboratory studies including: CBC, Chem-20 and urinalysis. - Willingness to comply with study protocol. Exclusion Criteria: - Pregnancy - Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal electrocardiogram (ECG). |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Institute for Neurodegenerative Disorders | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Institute for Neurodegenerative Disorders | Molecular NeuroImaging |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the imaging diagnosis, based on visual analysis and quantitative analysis, to the clinical diagnosis of the investigator blinded to the imaging results | 5 years | No | |
Secondary | Comparison of the DAT imaging diagnosis, initial diagnosis by the movement disorder experts and referral neurologist diagnosis to the 'gold standard' diagnosis | 5 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00132626 -
Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome
|
Phase 2 | |
Completed |
NCT00368199 -
Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes
|
N/A | |
Completed |
NCT00096876 -
A Study of the Sense of Smell in Relatives of Parkinson's Disease Patients
|
||
Completed |
NCT00117195 -
A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease
|
N/A | |
Completed |
NCT00117819 -
A Study of Brain Imaging With Nuclear Medicine Technology in Individuals With and at Risk for Parkinson's Disease
|
Phase 2 | |
Completed |
NCT04193527 -
A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients
|
Phase 3 | |
Completed |
NCT04974034 -
Movement Disorders Analysis Using a Deep Learning Approach
|
||
Completed |
NCT00354003 -
The Study of the Impact of Disclosing Imaging Study Information to Trial Participants
|
||
Completed |
NCT04925622 -
Complex Eye Movements in Parkinson's Disease and Related Movement Disorders
|
||
Completed |
NCT00315250 -
Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease
|
Phase 2 | |
Completed |
NCT00273351 -
Imaging and Genetic Biomarkers of Parkinson Disease (PD) Onset and Progression in High-risk Families
|
Phase 2 | |
Completed |
NCT00129181 -
Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease
|
N/A | |
Completed |
NCT00096720 -
Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease
|
Phase 2 | |
Recruiting |
NCT05110547 -
Multicenter Study of Blood Biomarkers of Mitochondrial and Peroxisomal Metabolism to Differentiate Idiopathic Parkinson's Disease From Related Conditions
|