Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subje
Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological Conditions
What it found
The trial ended early for another reason (see below).
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- [18F] PBR06
What it measured
Main measures
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
Smouldering inflammation
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Nov 2009
Main results due
Sept 2010
Finished
Sept 2010