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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00970333
First received: August 31, 2009
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Parkinson Disease
Multiple Sclerosis
Drug: [18F]-FEPPA
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of [18F] FEPPA and PET as a Marker of Inflammation in Subjects With Neurological Conditions

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970333

Locations
United States, Connecticut
Instiute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
  More Information

No publications provided

Responsible Party: Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00970333     History of Changes
Other Study ID Numbers: FEPPA 001
Study First Received: August 31, 2009
Last Updated: February 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
Alzheimer disease
Parkinson disease
Multiple Sclerosis

Additional relevant MeSH terms:
Parkinson Disease
Inflammation
Multiple Sclerosis
Alzheimer Disease
Sclerosis
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dementia
Tauopathies
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014