Clinical trial NCT01028209: Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological Conditions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer Disease
Parkinson Disease
Multiple Sclerosis
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: To evaluate [18F] PBR06 PET imaging as a tool to detect microglial activation in the brain of AD, PD and MS research participants.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: Danna Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References: