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

Phase 1

Terminated

• Conditions: Parkinson Disease; Alzheimer Disease; Multiple Sclerosis
• Interventions: Drug: [18F] PBR06

• Registration Number: NCT01028209
• Lead Sponsor: Institute for Neurodegenerative Disorders

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2010-09-22
• Study Completion: 2010-09-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assess [18F] PBR06 and PET imaging	[18F] PBR06	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States