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

This study is currently recruiting participants.
Verified November 2013 by Institute for Neurodegenerative Disorders
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: November 8, 2013
Last verified: November 2013
  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 ]

Estimated Enrollment: 80
Study Start Date: July 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970229

Contacts
Contact: Barbara Fussell, RN 203-401-4300

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders Recruiting
New haven, Connecticut, United States, 06510
Contact: Barbara Fussell, RN    203-401-4345    bfussell@indd.org   
Contact: Debbie Stottle    203 401 4336    dstottle@indd.org   
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: David Russell, MD Institute for Neurodegenerative Disorders
  More Information

No publications provided

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: November 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chorea
Huntington Disease
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 16, 2014