Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy Subjects

NCT01462708 | Completed Phase 1

• 1 other identifier: CB1-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Molecular NeuroImaging

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 2 years

Secondary Outcomes (1)

• To acquire safety data

  Approximately 2 years

Study Arms (1)

Assess [18F]MK-9470 and PET imaging

EXPERIMENTAL

To Assess \[18F\]MK-9470 and PET imaging

Drug: [18F]MK-9470

Interventions

[18F]MK-9470 DRUG

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.

Also known as: Parkinson Disease, Cannabinoid-1

Assess [18F]MK-9470 and PET imaging

Eligibility Criteria

• Age: 18 Years - 90 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 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
• 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

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related Links

• Institute for Neurodegenerative Disorders

MeSH Terms

Conditions

Parkinson Disease

Interventions

MK-9470

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Danna Jennings, 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: Danna Jennings, MD

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: October 31, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

US (1)