Alzheimer Disease, Multiple Sclerosis, Parkinson Disease
Conditions
Brief summary
The underlying goal of this study is to assess \[18F\] PBR06 PET imaging as a tool to detect microglial activation in the brain of Alzheimer Disease (AD), Parkinson Disease (PD) and Multiple Sclerosis (MS) research participants.
Interventions
DRUG[18F] PBR06
Subjects will be injected with 5mCi, not to exceed \>10% of 5mCI, of \[18F\]PBR06, followed by 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
Yes
Inclusion criteria
* 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 \[18F\]-PBR06 injection. * 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 \[18F\]-PBR06 injection. * 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 \[18F\]-PBR06 injection * The following criteria will be met for inclusion of healthy control subjects in this study: * The participant is 18 years or older. * Written informed consent is obtained. * Negative history of neurological or psychiatric illness based on evaluation by a research physician. * Clinical Dementia Rating score = 0. * For females, non-child bearing potential a negative urine or blood pregnancy test on day of \[18F\]-PBR06 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 * 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 * 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 * Healthy control 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate [18F] PBR06 PET imaging as a tool to detect microglial activation in the brain of AD, PD and MS research participants. | 1 year |
Countries
United States
Outcome results
None listed