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

• Sponsor: Institute for Neurodegenerative Disorders (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01028209
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 10.7
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Parkinson Disease; Multiple Sclerosis	Drug: [18F] PBR06	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Sep 22, 2010
• Actual Study Completion Date: Sep 22, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Institute for Neurodegenerative Disorders	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Institute for Neurodegenerative Disorders

Investigators

• Principal Investigator: Danna Jennings, MD, Institute for Neurodegenerative Disorders

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute for Neurodegenerative Disorders
• ClinicalTrials.gov Identifier: NCT01028209
• Other Study ID Numbers: PBR06 001
• First Posted: Dec 9, 2009
• Last Update Posted: Apr 3, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Parkinson Disease; Multiple Sclerosis; Alzheimer Disease

Study Results

No Results Posted as of Apr 3, 2019