Evaluation of [18F] FEPPA and PET Imaging as a Marker of Inflammation in Subjects With Neurological Conditions

February 7, 2012 updated by: Danna Jennings, MD, Institute for Neurodegenerative Disorders

Evaluation of [18F] FEPPA and PET as a Marker of Inflammation in Subjects With Neurological Conditions

Ultimately a marker of microglial activation could be used for large-scale quantitative brain imaging trials in Alzheimer Disease (AD), Parkinson Disease (PD) or Multiple Sclerosis (MS), specifically to investigate the agent as an objective biomarker in treatments aimed at reducing inflammatory changes in these conditions. The significance of this work lies in applying state-of-art quantitative neuroimaging tools to develop a relevant biomarker in individuals with neurodegenerative diseases with the intention of using this efficiently in large clinical imaging trials.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The adaptation of imaging agents like [18F]-FEPPA as a biomarker of microglial activation in neurodegenerative and neuroinflammatory diseases requires human validation studies. Expanding upon our previous work with B-amyloid ligands (123I-IMPY, 123I MNI-187) for AD and dopamine transporter ligands (123I B-CIT, Altropane) for PD, we desire to develop and characterize [18F]-FEPPA as a potential marker for microglial activation in association with neuronal damage that may be applicable to multiple neurodegenerative and inflammatory diseases.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Instiute for Neurodegenerative Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Alzheimer's disease patients will be recruited for this study. The following criteria will be met for inclusion of AD subjects in this study:

    • The participant is 50 years or older.
    • Written informed consent is obtained.
    • Participants have a clinical diagnosis of probable Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
    • Clinical Dementia Rating Scale score ≤ 2.
    • Modified Hachinski Ischemia Scale score of ≤ 4.
    • For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-FEPPA injection.

Exclusion Criteria:

  • Alzheimer's subjects will be excluded from participation for the following reasons:

    • The subject has a history of significant cerebrovascular disease.
    • 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.
    • Pregnancy

Inclusion Criteria:

  • The following criteria will be met for inclusion of PD subjects in this study:

    • The participant is 30 years or older.
    • Written informed consent is obtained.
    • Participants have a clinical diagnosis of Parkinson disease (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia).
    • Hoehn and Yahr ≤4.
    • For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-FEPPA injection.

Exclusion Criteria:

  • Parkinson's subjects will be excluded from participation for the following reasons:

    • 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.
    • Pregnancy

Inclusion Criteria:

  • Multiple Sclerosis Subject Selection. Subjects who have a clinical diagnosis of Multiple Sclerosis (MS) will be recruited for this study. The following criteria will be met for inclusion of MS subjects in this study:

    • The participant is 18 years or older.
    • Written informed consent is obtained.
    • Participants have a clinical diagnosis of Multiple Sclerosis (per the 2005 Revised McDonald Criteria; Polman, et al., 2005).
    • Kurtzke Expanded Disability Status Scale (EDSS) ≤ 7.5.
    • For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-FEPPA injection.

Exclusion Criteria:

  • MS subjects will be excluded from participation for the following reasons:

    • 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.
    • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: assess [18F]-FEPPA PET imaging
Drug: [18F]-FEPPA
Subjects will be injected with up to 5 mCi and not to exceed 5.5mCi (not >10% of 5 mCi limit) of [18F]-FEPPA followed by serial PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]-FEPPA.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Neurodegenerative Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (ESTIMATE)

September 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEPPA 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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