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

NCT01461083 | Completed Phase 1 DMC

• 1 other identifier: MPPF
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; [18F]MPPF

Outcome Measures

Primary Outcomes (1)

• To assess the dynamic uptake and washout of [18F]MPPF in brain using positron emission tomography(PET) imaging

  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.

  2 years

Secondary Outcomes (1)

• To assess the influence of dopaminergic replacement therapy on 5HT1A activity in PD subjects

  2 years

Study Arms (1)

Assess [18F]MPPF and PET imaging

EXPERIMENTAL

To assess \[18F\]MPPF and PET imaging

Drug: [18F]MPPF

Interventions

[18F]MPPF DRUG

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

Assess [18F]MPPF 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).
• 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.

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead

Study Sites (1)

Molecular NeuroImaging, LLC

New Haven, Connecticut, 06510, United States

Location

Related Links

• Institute for Neurodegenerative Disorders

MeSH Terms

Conditions

Parkinson Disease

Interventions

4-(2'-methoxyphenyl)-1-(2'-(N-2'-pyridinyl)-p-(18F)fluorobenzamido )ethylpiperazine

Condition Hierarchy (Ancestors)

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

Study Officials

• David Russell, MD, PhD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: October 27, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2014
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (1)