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Sponsors and Collaborators: |
Institute for Neurodegenerative Disorders Molecular NeuroImaging |
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Information provided by: | Institute for Neurodegenerative Disorders |
ClinicalTrials.gov Identifier: | NCT00427674 |
The overall plan of this project is to evaluate [123I] mZINT as a tool to assess SERT density in humans. This protocol will be completed in three parts. In Part A serial dynamic SPECT will be acquired after injection of [123I] mZINT in healthy controls to assess regional brain uptake in human subjects. If Part A demonstrates robust brain region specific uptake, then Part B - additional studies in healthy subjects to assess biodistribution, and Part C - studies in PD subjects to compare regional uptake to healthy controls, will be completed.
Condition | Intervention | Phase |
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Parkinson Disease |
Procedure: [123I] mZINT injection and serial dynamic SPECT imaging |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Evaluation of (123-I)MZINT as a Brain SPECT Tracer of Serotonin Transporters in Healthy Human Subjects |
Estimated Enrollment: | 15 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 (6 -Part A and 4 - Part B) healthy subjects and 10 PD subjects will be recruited from the IND databases, patient spouses, and the community to participate in this protocol. The study doctor will discuss the study procedures and evaluate the subject for eligibility. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, and a baseline physical and neurological evaluation.
Following bolus intravenous injection of 5 mCi of 123-I mZINT over 15 seconds, serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity. Venous blood measures will be obtained with each acquisition and characterization of 123-I mZINT and metabolites will be assessed. Safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKG.
Vital signs will be assessed at pre-injection baseline and 15, 30, 60, and 90 minutes following the infusion of 123-I mZINT. An EKG will be obtained at baseline and at 20 and 40 min post 123-I mZINT injection. Adverse events will be assessed when vital signs are obtained. Clinical laboratory tests performed at baseline and after each injection including the following: serum chemistry battery, complete blood count with differential, and urinalysis.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Health Control:
Parkinson disease:
Willingness to comply with the study protocol
Exclusion Criteria:
All Subjects will be excluded from participation for the following reasons:
Contact: Elizabeth Paul | 203-401-4300 | epaul@indd.org |
Contact: Susan Mendick, MPH | 203-401-4300 |
United States, Connecticut | |
Institute for Neurodegenerative Disorders | Recruiting |
New Haven, Connecticut, United States, 06510 | |
Contact: Elizabeth Paul 203-401-4300 Epaul@indd.org | |
Principal Investigator: John Seibyl, MD | |
Sub-Investigator: Danna Jennings, MD | |
Sub-Investigator: Kenneth Marek, MD |
Principal Investigator: | John P Seibyl, MD | Institute for Neurodegenerative Disorders |
Responsible Party: | MNI ( John Seibyl, MD ) |
Study ID Numbers: | _mZINT_001/002 |
Study First Received: | January 25, 2007 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00427674 |
Health Authority: | United States: Food and Drug Administration |
Parkinson Imaging |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases Central Nervous System Diseases |
Healthy Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Serotonin |
Nervous System Diseases |