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

NCT00970229 | Completed Phase 1

• 1 other identifier: MNI-420-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Huntington Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate [123I]MNI-420 as a quantitative imaging outcome measure of A2aR activity in PD, HD, and healthy subjects

  1 year

Study Arms (1)

Assess [123I]MNI-420 and SPECT Imaging

EXPERIMENTAL

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

Drug: [123I]MNI-420

Interventions

[123I]MNI-420 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.

Assess [123I]MNI-420 and SPECT Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Huntington Disease

Interventions

7-(2-(4-(2-fluoro-4-iodophenyl)piperazin-1-yl)ethyl)-2-(furan-2-yl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidin-5-amine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• David Russell, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 2, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

US (1)