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

NCT00970333 | Completed Phase 1

• 1 other identifier: FEPPA 001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Parkinson Disease; Multiple Sclerosis

Keywords

Alzheimer disease; Parkinson disease; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (1)

assess [18F]-FEPPA PET imaging

EXPERIMENTAL

Drug: [18F]-FEPPA

Interventions

[18F]-FEPPA DRUG

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

assess [18F]-FEPPA PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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
• The participant is 18 years or older.

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead

Study Sites (1)

Instiute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Multiple Sclerosis

Interventions

N-(2-((N-(4-phenoxypyridin-3-yl)acetamido)methyl)phenoxy)ethyl fluoride

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System 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: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 2, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 8, 2012

Record last verified: 2012-02

Locations

US (1)