Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological Conditions

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.

Intervention(s) in this Clinical Trial

• Drug: [18F] PBR06
  • Subjects will be injected with 5mCi, not to exceed >10% of 5mCI, of [18F]PBR06, followed by PET imaging.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Assess [18F] PBR06 and PET imaging

Primary Measures

• To evaluate [18F] PBR06 PET imaging as a tool to detect microglial activation in the brain of AD, PD and MS research participants.
  • Time Frame: 1 year
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Institute for Neurodegenerative Disorders Other

Overall Clinical Trial Officials and Contacts

Danna Jennings, MD Principal Investigator Institute for Neurodegenerative Disorders  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01028209

Study ID Number: PBR06 001

ClinicalTrials.gov Identifier: NCT01028209

Health Authority: United States: Food and Drug Administration