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



Status:Terminated
Conditions:Alzheimer Disease, Parkinsons Disease, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:November 2009
End Date:September 22, 2010

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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.


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
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