Measuring Brain Inflammation in Autism



Status:Recruiting
Conditions:Infectious Disease, Neurology, Psychiatric, Psychiatric, Autism
Therapuetic Areas:Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 35
Updated:10/24/2018
Start Date:April 11, 2017
End Date:December 2019
Contact:Michael Gandal, MD PhD
Email:autismresearch@ucla.edu
Phone:310-267-4798

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Targeting Microglial Activation for Treatment of Autism Spectrum Disorder (ASD): A Proof-of-Concept, Target-Engagement Study

Autism spectrum disorders (ASD) are highly disabling, persistent neurodevelopmental
disorders. There are no available treatments for core symptoms of ASD or biologically-based
clinical biomarkers. Emerging evidence indicates that levels of brain inflammation are
increased in ASD. In particular, recent work implicates hyperactivity of microglial cells,
the resident immune cells of the brain. However, the functional consequences of microglial
activation remain unknown. This study will measure microglial activation in ASD using
positron emission tomography (PET) brain imaging. Adult males with ASD (n=15) and healthy
controls (n=15) will be recruited for this study and undergo comprehensive clinical and
behavioral baseline assessment. All subjects will then undergo baseline PET imaging using a
radiotracer that labels activated microglia. Subjects with ASD will then undergo 12-week open
label treatment with minocycline, an FDA-approved antibiotic thought to block microglial
activation. PET imaging will be repeated at 12 weeks to confirm target engagement. A subset
of control subjects will also undergo repeat PET imaging to determine test-retest
reliability. During minocycline treatment, ASD subjects will be evaluated every 2 weeks for
safety, clinical impression, behavioral functioning, and measures of cognition. Results will
provide important information regarding the relationship between levels of brain
inflammation, cognitive and behavioral function in ASD.


Inclusion criteria for participants with ASD

1. Male with a diagnosis of ASD as defined by DSM-5, confirmed by clinical evaluation and
ADOS-2.

2. Age 18-35 years inclusive

3. IQ estimate of >70 on VIQ or PIQ

4. Capacity to consent to research

5. Ability to comply with all protocol procedures and assessments

6. Availability of an informant willing to provide information regarding subject behavior
and health status (Note: Informant role requires a responsible adult with close,
ongoing contact and knowledge of the subject; parent/caregiver acceptable, but not
necessary for role)

Exclusion criteria for participants with ASD

1. Evidence of current nicotine, drug, or alcohol abuse or dependence

2. Presence of a chronic medical condition which would potentially influence the
assessment of TSPO binding, or interact with study medication (eg. hepatic,
neurologic, renal disease) to increase risk to the subject

3. Presence of severe behavioral disturbance likely to require initiation of treatment
during the course of the protocol

4. Clinical judgment of the study physician of inability to perform the requirements of
the study

5. Current or recent (past 30 days) treatment with minocycline or related compounds,
immunosuppressives, or benzodiazepines

6. Homozygous genotype for minor allele of rs6971

7. History of recent febrile illness in past 30 days

8. History of allergic reactions to tetracycline antibiotics

9. Concomitant medication treatment not stable for the 4 weeks prior to study entry or
anticipated to change

10. Current prescribed medication likely to confound assessment of TSPO binding

Inclusion criteria for healthy volunteer participants

1. Male in good general health, confirmed by clinical evaluation

2. Age 18-35 years inclusive

3. IQ estimate of >70 on VIQ or PIQ

4. Ability to comply with all protocol procedures and assessments

Exclusion criteria for healthy volunteer participants

1. Diagnosis of an autism spectrum disorder (ASD)

2. Evidence of current nicotine, drug, or alcohol abuse or dependence

3. Presence of a chronic medical condition which would potentially influence the
assessment of TSPO binding, or interact with study medication (eg. hepatic,
neurologic, renal disease) to increase risk to the subject

4. Presence of current or lifetime severe psychopathology potentially confounding
assessment of TSPO binding (psychosis, severe depression, bipolar disorder,
Obsessive-Compulsive Disorder)

5. Current prescribed medication likely to confound assessment of TSPO binding

6. Clinical judgment of the study physician of inability to perform the requirements of
the study

7. Current or recent (past 30 days) treatment with minocycline or related compounds,
immunosuppressives, benzodiazepines, or psychotropic medications likely to confound
assessment of TSPO binding

8. Homozygous genotype for minor allele of rs6971

9. SRS-2 T-score score of >59

10. History of recent febrile illness in past 30 days
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Phone: 310-267-4798
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