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Assessment of the Biodistribution and Safety of 123-I MZINT in Healthy Subjects and Parkinson Disease Patients

This study has been terminated.
(Scan results to date did not show reason to continue with study)
Sponsor:
Collaborator:
Molecular NeuroImaging
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00427674
First received: January 25, 2007
Last updated: October 5, 2010
Last verified: October 2010
History of Changes
  Purpose

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
Parkinson Disease
 Drug: [123I] mZINT injection and serial dynamic SPECT imaging
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase I Evaluation of (123-I)MZINT as a Brain SPECT Tracer of Serotonin Transporters in Healthy Human Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • Measurement of 123-mZINT brain uptake and distribution [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
  • pharmacokinetics of brain uptake and washout [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • measurement of biodistribution and radiation absorbed dose of 123-I MZINT in the brain SERT [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
  • Evaluation for reduction in midbrain and/or striatal SERT density using 123-I MZINT. [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: injection of 5 mCi of 123-I mZINT Drug: [123I] mZINT injection and serial dynamic SPECT imaging
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Health Control:

  • The subject is aged 18-70.
  • Written informed consent is obtained.
  • The participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
  • For females, non-child bearing potential or negative urine pregnancy test on day of [123I] mZINT injection.
  • Willingness to comply with the study protocol

Parkinson disease:

  • The subject is aged 18-70.
  • Participants have a clinical diagnosis (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) of idiopathic Parkinson's disease.
  • Hoehn and Yahr stages < 3.
  • Written informed consent is obtained.
  • The participant has no clinically significant clinical laboratory value and/or clinically significant unstable medical, neurological or psychiatric illness.
  • For females, non-child bearing potential or negative urine pregnancy test on day of [123I] mZINT injection.

Willingness to comply with the study protocol

Exclusion Criteria:

All Subjects will be excluded from participation for the following reasons:

  • The subject has a clinically significant clinical laboratory values abnormality, and/or medical or psychiatric illness.
  • The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
  • The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
  • Use of all prescription drugs or non-prescriptions drugs that may effect serotonin such as antidepressants including sertraline, fluoxetine, fluvoxamine, venlafaxine.
  • The participant has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) {American Psychiatric Association, 1994 #2} within the past 2 years.
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427674

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Molecular NeuroImaging
Investigators
Principal Investigator: John P Seibyl, MD Institute for Neurodegenerative Disorders
  More Information

No publications provided

Responsible Party: John Seibyl, MD, MNI
ClinicalTrials.gov Identifier: NCT00427674     History of Changes
Other Study ID Numbers: _mZINT_001/002
Study First Received: January 25, 2007
Last Updated: October 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
Parkinson
Imaging

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 19, 2013