Alzheimer Disease, Multiple Sclerosis, Parkinson Disease
Conditions
Keywords
Alzheimer disease, Parkinson disease, Multiple Sclerosis
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.
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.
Interventions
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
Sponsors
Institute for Neurodegenerative Disorders
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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. | one year |
Countries
United States
Outcome results
None listed