Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in PD, HD and Healthy Subjects.

NCT ID: NCT00970229

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2015-05-31

Brief Summary

The underlying goal of this study is to assess [123I]MNI-420 SPECT imaging as a tool to detect A2aR density in the brain of PD and HD research participants to be compared with similarly aged healthy subjects.

Detailed Description

• To assess the dynamic uptake and washout of [123I]MNI-420 in brain using single photon emission computed tomography (SPECT) in Parkinson's disease (PD), Huntington's disease (HD), and similarly aged healthy subjects as a potential imaging biomarker of adenosine receptor type A2a (A2aR) in brain
• To acquire initial safety data following injection of [123I]MNI-420

Conditions

Parkinson Disease; Huntington Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Assess [123I]MNI-420 and SPECT Imaging

To assess \[123I\]MNI-420 and SPECT Imaging in PD, HD subjects and similarly aged healthy subjects.

Group Type: EXPERIMENTAL

[123I]MNI-420

Intervention Type: DRUG

Subjects will be injected with 8mCi, not to exceed 8.8 mCi (not \> 10% of 8 mCi limit)of \[123I\]MNI-420, followed by SPECT imaging.

Interventions

[123I]MNI-420

Subjects will be injected with 8mCi, not to exceed 8.8 mCi (not \> 10% of 8 mCi limit)of \[123I\]MNI-420, followed by SPECT imaging.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Parkinson Subject Selection. Subjects who have a clinical diagnosis of PD will be recruited for this study. The following criteria will be met for inclusion of PD subjects in this study:

• The participant is 30 years or older.
• Written informed consent is obtained.
• Participants have a clinical diagnosis of Parkinson disease based on UK Brain Bank Criteria
• For females, non-child bearing potential or negative urine pregnancy test on day of [123I]MNI-420 injection.
• Huntington Disease Subject Selection. Subjects with a diagnosis of HD will be recruited for this study. The following criteria will be met for inclusion of HD subjects in this study:

• The participant is 18 years or older.
• Written informed consent is obtained.
• Participants have a clinical diagnosis of symptomatic Huntington disease with genetic confirmation
• Subject is able to provide informed consent as judged by the investigator, or assent can be obtained from the subject and informed consent provided by the appropriate legal representative or next of kin.
• For females of child-bearing potential, a negative urine pregnancy test on day of [123I]MNI-420 injection.
• Healthy Control Subject Selection. Healthy control subjects who have no neurological disease will be recruited for this study. The following criteria will be met for inclusion of healthy control subjects in this study:

• The participant is 18 years or older.
• Written informed consent is obtained.
• Negative history of neurological or psychiatric illness based on evaluation by a research physician.
• For females, non-child bearing potential or negative urine or blood pregnancy test on day of [123I]MNI-420 injection.

Exclusion Criteria

• Parkinson subjects will be excluded from participation for the following reasons:

• The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
• The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).
• The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
• Clinically significant evidence of vascular disease or alternative neurologic disorder
• Pregnancy
• Huntington disease subjects will be excluded from participation for the following reasons:

• The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
• The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).
• The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
• Pregnancy
• Clinically significant evidence of vascular disease or alternative neurologic disorder
• Healthy control subjects will be excluded from participation for the following reasons:

• The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
• The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).
• The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
• Pregnancy
• Clinically significant evidence of vascular disease or neurologic disorder

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Neurodegenerative Disorders

OTHER

Sponsor Role: lead

Responsible Party

David Russell, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Russell, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Neurodegenerative Disorders

Locations

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

MNI-420-01

Identifier Type: -

Identifier Source: org_study_id