Parkinson DiseasePhase 1MK9470NCT01462708
Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects
A Phase 1 study testing [18F]MK-9470 in people with Parkinson Disease, run by Institute for Neurodegenerative Disorders at 1 site in United States.
Trial summary
The purpose of this study is to assess MK-9470 Positron Emission Tomography (PET) imaging as a tool to evaluate the activity of the CB-1 receptor in the brain. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- [18F]MK-9470
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2013
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a diagnosis of PD (based on UK Brain Bank Criteria) within the past 2 years.
- Modified Hoehn and Yahr stages 1-2.
- No evidence of dyskinesia by history or clinical examination
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-MK-9470 injection.
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- Advanced PD subjects
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a diagnosis of PD (based on UK Brain Bank Criteria) of at least 5 years duration.
- Modified Hoehn and Yahr stages 1-4.
- No evidence of dyskinesia by history or clinical examination
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-MK-9470 injection.
- Subjects who have a clinical diagnosis of advanced PD with dyskinesia will be recruited for this study.
- ePD subjects
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a diagnosis of PD (based on UK Brain Bank Criteria) of at least 5 years.
- Modified Hoehn and Yahr stages 1-4.
- Evidence of dyskinesia either by history or clinical examination
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-MK-9470 injection.
- PD (all stages- e-PD, aPD, aPD-dys)Subject Selection. Subjects who have a clinical diagnosis of ePD, aPD, aPD-dys will be recruited for this study.
- All PD subjects
- 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 a negative urine or blood pregnancy test on day of [18F]-MK9470 injection.
Who cannot join
- 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.
- The patient has evidence of unstable gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, pulmonary, or other disorder or disease.
- Evidence of a stroke or mass lesion in a clinically relevant area that may interfere with the imaging outcome measure
- Subjects with radiation exposure above acceptable levels
- Pregnancy
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- Healthy Control Subject Selection: subjects who have no neurological disease will be recruited for this study.
- Healthy control subjects
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
- Subjects with radiation exposure above acceptable levels
- Pregnancy
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 [18F] MK-9470 and PET as a Marker of Cannabinoid-1 Receptor Activity in Subjects With Parkinson Disease Compared With Healthy Controls
The purpose of this study is to assess MK-9470 Positron Emission Tomography (PET) imaging as a tool to evaluate the activity of the CB-1 receptor in the brain.
Read the detailed description
The underlying goal of this study is to assess MK-9470 PET imaging as a tool to evaluate the activity of the CB-1 receptor in the brain of Parkinson's Disease (PD) research participants.
- Conditions
- Parkinson Disease
- Being tested
- [18F]MK-9470
- Keywords
- Parkinson Disease, Molecular NeuroImaging
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]MK-9470Drug
Also called Parkinson Disease, Cannabinoid-1
Subjects will be injected with 10 mCi, and not to exceed 11 mCi (not >10% of 10 mCi limit)of [18F]MK-9470, followed by PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| Assess [18F]MK-9470 and PET imaging | Experimental | To Assess [18F]MK-9470 and PET imaging Receives: Drug: [18F]MK-9470 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic uptake and washout of [18F]MK-9470
To assess the dynamic uptake and washout of [18F]-MK-9470 in brain using positron emission tomography (PET) in early Parkinson disease and advanced Parkinson disease with and without dyskinesia and similarly aged healthy control subjects as a potential imaging biomarker of the cannabionoid-1 (CB-1) receptor in brain.
Measured: Approximately 2 years
Secondary outcomes (1)
To acquire safety data
Safety will be assessed by the number of adverse events experienced by subjects and any clinically significant changes in laboratory tests or vital signs.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2013
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danna Jennings, MD, Institute for Neurodegenerative Disorders
- Investigators
- Danna Jennings, MD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462708
- Sponsor's protocol ID
- CB1-01
- Acronym
- MK9470
- Status last verified
- Nov 2013
- First submitted
- 8 Jun 2011
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [18F] MK-9470 and PET as a Marker of Cannabinoid-1 Receptor Activity in Subjects With Parkinson Disease Compared With Healthy Controls
- ClinicalTrials.gov ID
- NCT01462708
- Acronym / sponsor ID
- MK9470 / CB1-01
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Molecular NeuroImaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 31 Oct 2011 (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 purpose of this study is to assess MK-9470 Positron Emission Tomography (PET) imaging as a tool to evaluate the activity of the CB-1 receptor in the brain.
Detailed description
The underlying goal of this study is to assess MK-9470 PET imaging as a tool to evaluate the activity of the CB-1 receptor in the brain of Parkinson's Disease (PD) research participants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess [18F]MK-9470 and PET imaging | Experimental | Drug: [18F]MK-9470To Assess [18F]MK-9470 and PET imaging |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a diagnosis of PD (based on UK Brain Bank Criteria) within the past 2 years.
- Modified Hoehn and Yahr stages 1-2.
- No evidence of dyskinesia by history or clinical examination
Key exclusion criteria (13 listed)
- 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.
- The patient has evidence of unstable gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, pulmonary, or other disorder or disease.
- Evidence of a stroke or mass lesion in a clinically relevant area that may interfere with the imaging outcome measure
- Subjects with radiation exposure above acceptable levels
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 |
|---|---|---|
| [18F]MK-9470Also: Parkinson Disease, Cannabinoid-1Subjects will be injected with 10 mCi, and not to exceed 11 mCi (not >10% of 10 mCi limit)of [18F]MK-9470, followed by PET imaging. | Drug | Assess [18F]MK-9470 and PET imaging |
Primary outcome
Dynamic uptake and washout of [18F]MK-9470
Time frame: Approximately 2 years
To assess the dynamic uptake and washout of [18F]-MK-9470 in brain using positron emission tomography (PET) in early Parkinson disease and advanced Parkinson disease with and without dyskinesia and similarly aged healthy control subjects as a potential imaging biomarker of the cannabionoid-1 (CB-1) receptor in brain.
1 secondary outcome
To acquire safety data
Time frame: Approximately 2 years
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 11 Nov 2013.
- Institute for Neurodegenerative DisordersLink provided by the sponsor.
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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.
Danna Jennings, 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 [18F]MK-9470 in people with Parkinson 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 27 inclusion and 13 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 11 Nov 2013. 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?
Dynamic uptake and washout of [18F]MK-9470 (time frame: Approximately 2 years). 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 11 Nov 2013.