Parkinson DiseasePhase 1MNI-420NCT00970229
Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in PD, HD and Healthy Subjects.
A Phase 1 study testing [123I]MNI-420 in people with Parkinson Disease and Huntington Disease, run by Institute for Neurodegenerative Disorders at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Huntington Disease
- What is being tested?
- [123I]MNI-420
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
About this study
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
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.
Read the 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
- Being tested
- [123I]MNI-420
- Medical subject headings
- Parkinson Disease, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[123I]MNI-420Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [123I]MNI-420 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate [123I]MNI-420 as a quantitative imaging outcome measure of A2aR activity in PD, HD, and healthy subjects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Russell, MD, PhD, Institute for Neurodegenerative Disorders
- Investigators
- David Russell, MD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970229
- Sponsor's protocol ID
- MNI-420-01
- Acronym
- MNI-420
- Status last verified
- Jan 2017
- First submitted
- 31 Aug 2009
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00970229
- Acronym / sponsor ID
- MNI-420 / MNI-420-01
- Conditions
- Parkinson Disease, Huntington Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess [123I]MNI-420 and SPECT Imaging | Experimental | Drug: [123I]MNI-420To assess [123I]MNI-420 and SPECT Imaging in PD, HD subjects and similarly aged healthy subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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:
- 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:
Key exclusion criteria (18 listed)
- Parkinson subjects will be excluded from participation for the following reasons:
- Huntington disease subjects will be excluded from participation for the following reasons:
- Healthy control subjects will be excluded from participation for the following reasons:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [123I]MNI-420Subjects 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. | Drug | Assess [123I]MNI-420 and SPECT Imaging |
Primary outcome
To evaluate [123I]MNI-420 as a quantitative imaging outcome measure of A2aR activity in PD, HD, and healthy subjects
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Russell, MD principal investigator
Institute for Neurodegenerative Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [123I]MNI-420 in people with Parkinson Disease and Huntington Disease, run by Institute for Neurodegenerative Disorders at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate [123I]MNI-420 as a quantitative imaging outcome measure of A2aR activity in PD, HD, and healthy subjects (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.