Status:
COMPLETED
Evaluation of [18F] FEPPA and PET Imaging as a Marker of Inflammation in Subjects With Neurological Conditions
Lead Sponsor:
Institute for Neurodegenerative Disorders
Conditions:
Alzheimer Disease
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00970333
Start Date
August 1 2009
End Date
October 1 2010
Last Update
February 8 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instiute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510