Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological Conditions
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease Parkinson Disease Multiple Sclerosis |
Drug: [18F] PBR06 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2009 |
| Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Assess [18F] PBR06 and PET imaging |
Drug: [18F] PBR06
Subjects will be injected with 5mCi, not to exceed >10% of 5mCI, of [18F]PBR06, followed by PET imaging.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Connecticut | |
| Institute for Neurodegenerative Disorders | |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: | Danna Jennings, MD | Institute for Neurodegenerative Disorders |
More Information
No publications provided
| Responsible Party: | Danna Jennings, MD / Principal Investigator, Institute for Neurodegenerative Disorders |
| ClinicalTrials.gov Identifier: | NCT01028209 History of Changes |
| Other Study ID Numbers: | PBR06 001 |
| Study First Received: | December 8, 2009 |
| Last Updated: | October 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Multiple Sclerosis Parkinson Disease Sclerosis Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013