Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects (MK9470)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: [18F]MK-9470 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
- To determine the functional activity of cannabinoid receptor in advanced Parkinson disease (aPD) and advanced Parkinson disease with dyskinesia (aPD-dys) and compare with early PD (ePD) and healthy control subjects. [ Time Frame: Approximately 2 years ] [ Designated as safety issue: Yes ]To determine if [18F]-MK-9470 distinguishes PD subjects from similarly aged healthy control subjects and to acquire safety data following injection of [18F]-MK-9470.
- To obtain test/retest reproducibility of quantitative PET outcome measures with [18F] -MK-9470 [ Time Frame: Approximately 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 32 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Assess [18F]MK-9470 and PET imaging
To Assess [18F]MK-9470 and PET imaging
|
Drug: [18F]MK-9470
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.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Early PD Subjects
Inclusion criteria:
- 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.
Advanced PD subjects
Inclusion criteria:
- 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
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Healthy Control Subject Selection: subjects who have no neurological disease will be recruited for this study.
Healthy control subjects
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Contacts and Locations| Contact: Barbara Fussell, RN | 800-401-6067 | bfussell@indd.org |
| Contact: Pam Becker, RN | 203-401-4344 |
| United States, Connecticut | |
| Institute for Neurodegenerative Disorders | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Barbara Fussell, RN 800-401-6067 bfussell@indd.org | |
| Contact: Pam Becker, RN 203-401-4344 | |
| Principal Investigator: | Danna Jennings, MD | Institute for Neurodegenerative Disorders |
More Information
Additional Information:
No publications provided
| Responsible Party: | Danna Jennings, MD, Institute for Neurodegenerative Disorders |
| ClinicalTrials.gov Identifier: | NCT01462708 History of Changes |
| Other Study ID Numbers: | CB1-01 |
| Study First Received: | June 8, 2011 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Institute for Neurodegenerative Disorders:
|
Parkinson Disease Molecular NeuroImaging |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 19, 2013