Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a (MPPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461083
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
David Russell, MD, PhD, Institute for Neurodegenerative Disorders

Brief Summary:
The underlying goal of this study is to assess [18F]MPPF PET imaging as a tool to evaluate the activity of the serotonin 5HT1a receptor in the brain of Parkinson Disease (PD) research participants.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: [18F]MPPF Phase 1

Detailed Description:

Approximately 40 subjects with Parkinson disease and 20 healthy control subjects will be recruited to participate in the 2 Projects in this study. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations.

Subjects in Project 1 (20 PD and 20 HC subjects) will be asked to undergo a single bolus injection of [18F]MPPF followed by serial Positron Emission Tomography (PET) imaging scans and blood sampling for measurement of [18F]MPPF in plasma (both protein bound and free) over a period of up to 2 hours. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]MPPF. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD subjects will be compared with the HC subjects.

Subjects participating in Project 2 (20 PD subjects on dopaminergic replacement therapy) will also undergo a second [18F]MPPF and PET imaging session, identical except that PD medications will be withheld for approximately 8 hours prior to the imaging session. The second session will occur greater than 7 days, but not more than 3 months, from the first imaging session. Initial 'on' medication quantitative outcomes for each brain region will be compared to the outcomes from the second 'off' medication imaging session to determine the influence of dopaminergic treatment on 5HT1A activity.

The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]MPPF. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD subjects will be compared with the HC subjects.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase I Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a in Subjects With Parkinson Disease and Healthy Subjects
Study Start Date : September 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Assess [18F]MPPF and PET imaging
To assess [18F]MPPF and PET imaging
Drug: [18F]MPPF
Subjects will be dosed by intravenous bolus injection of [18F]MPPF targeted to be 5.0 mCi, and not to exceed 5.5 mCi (not >10% of 5.0 mCi limit) and not to exceed 5 µg of MPPF




Primary Outcome Measures :
  1. To assess the dynamic uptake and washout of [18F]MPPF in brain using positron emission tomography(PET) imaging [ Time Frame: 2 years ]
    To assess the dynamic uptake and washout of [18F]MPPF in brain using positron emission tomography (PET) in Parkinson disease and similarly aged healthy control subjects as a potential imaging biomarker of the serotonin (5HT1A) receptor in brain.


Secondary Outcome Measures :
  1. To assess the influence of dopaminergic replacement therapy on 5HT1A activity in PD subjects [ Time Frame: 2 years ]
    To assess the influence of dopaminergic replacement therapy on 5HT1A activity in PD subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  • Modified Hoehn and Yahr stage of 1 - 4.
  • For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F] CFPyPB injection.

Exclusion Criteria:

  • The subject has a clinically significant 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 subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, 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
  • Subject treated with medication known to interfere with [18F]MPPF binding in vivo (e.g. pindolol)
  • Subjects with radiation exposure above acceptable levels, i.e. a history of exposure to any radiation >15 mSv over the past 12 months.

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]MPPF 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.
  • Evidence of a stroke or mass lesion in a clinically relevant area that may interfere with the imaging outcome measure
  • Subject treated with medication known to interfere with [18F]MPPF binding in vivo (e.g. pindolol)
  • Subjects with radiation exposure above acceptable levels, i.e. a history of exposure to any radiation >15 mSv over the past 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461083


Locations
Layout table for location information
United States, Connecticut
Molecular NeuroImaging, LLC
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
Layout table for investigator information
Principal Investigator: David Russell, MD, PhD Institute for Neurodegenerative Disorders
Additional Information:
Layout table for additonal information
Responsible Party: David Russell, MD, PhD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT01461083    
Other Study ID Numbers: MPPF
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014
Keywords provided by David Russell, MD, PhD, Institute for Neurodegenerative Disorders:
Parkinson Disease
[18F]MPPF
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases