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

Primary Purpose

Parkinson Disease

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

[123I] mZINT injection and serial dynamic SPECT imaging

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Parkinson, Imaging

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Institute for Neurodegenerative Disorders

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

injection of 5 mCi of 123-I mZINT

Arm Description

Outcomes

Primary Outcome Measures

Measurement of 123-mZINT brain uptake and distribution

pharmacokinetics of brain uptake and washout

measurement of biodistribution and radiation absorbed dose of 123-I MZINT in the brain SERT

Evaluation for reduction in midbrain and/or striatal SERT density using 123-I MZINT.

Secondary Outcome Measures

Full Information

NCT ID

NCT00427674

First Posted

January 25, 2007

Last Updated

October 5, 2010

Sponsor

Institute for Neurodegenerative Disorders

Collaborators

Molecular NeuroImaging

1. Study Identification

Unique Protocol Identification Number

NCT00427674

Brief Title

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

Official Title

Phase I Evaluation of (123-I)MZINT as a Brain SPECT Tracer of Serotonin Transporters in Healthy Human Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Terminated

Why Stopped

Scan results to date did not show reason to continue with study

Study Start Date

January 2007 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Institute for Neurodegenerative Disorders

Collaborators

Molecular NeuroImaging

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Parkinson, Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

injection of 5 mCi of 123-I mZINT

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

[123I] mZINT injection and serial dynamic SPECT imaging

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement of 123-mZINT brain uptake and distribution

Time Frame

1 yr

Title

pharmacokinetics of brain uptake and washout

Time Frame

1 year

Title

measurement of biodistribution and radiation absorbed dose of 123-I MZINT in the brain SERT

Time Frame

1 yr

Title

Evaluation for reduction in midbrain and/or striatal SERT density using 123-I MZINT.

Time Frame

1 yr

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P Seibyl, MD

Organizational Affiliation

Institute for Neurodegenerative Disorders

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute for Neurodegenerative Disorders

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

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

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