Multiple Sclerosis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT01028209

Recruitment Status:

Terminated

Sponsor:

Institute for Neurodegenerative Disorders

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There is 1 Location for this study

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Institute for Neurodegenerative Disorders
New Haven Connecticut, 06510, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT01028209

Recruitment Status:

Terminated

Sponsor:


Institute for Neurodegenerative Disorders

How clear is this clinincal trial information?

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