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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Russell, MD, PhD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00970229
First received: August 31, 2009
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Parkinson Disease
Huntington Disease
Drug: [123I]MNI-420
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in Subjects With Parkinson Disease, Huntington Disease, and Healthy Controls

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • To evaluate [123I]MNI-420 as a quantitative imaging outcome measure of A2aR activity in PD, HD, and healthy subjects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: July 2009
Study Completion Date: May 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Assess [123I]MNI-420 and SPECT Imaging
To assess [123I]MNI-420 and SPECT Imaging in PD, HD subjects and similarly aged healthy subjects.
Drug: [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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970229

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders
New haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: David Russell, MD Institute for Neurodegenerative Disorders
  More Information

Responsible Party: David Russell, MD, PhD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00970229     History of Changes
Other Study ID Numbers: MNI-420-01 
Study First Received: August 31, 2009
Last Updated: January 5, 2017
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Huntington Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dementia
Chorea
Dyskinesias
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on January 17, 2017