A Study of the Association Between Autism and Immune Changes in the Brain

Stopped early

Conditions studied: Autism Spectrum Disorders, Brain Disease, Autism, Healthy Volunteers

In brief

Background: \- People with autism and autism spectrum disorders have problems with communication, behavior, and socializing, and many also have intellectual and developmental disabilities. The cause of autism is not known, but previous research has suggested an association between autism and immune changes in the brain. Researchers are interested in using the experimental radioactive drug (11C)PBR28, which attaches to a protein in the brain that is involved in immune changes, in positron emission tomography (PET) scanning of people with and without autism to see if there are greater immune changes in those with autism. Objectives: \- To determine if positron emission tomography scanning can be used to evaluate changes in an immune system protein in the brains of people with autism. Eligibility: \- Individuals between 18 and 45 years of age who have been diagnosed with either autism or autism spectrum disorders, or are healthy volunteers. Design: * Participants will be screened with a physical examination and psychological examination, medical history, questionnaires about behavior and mood, and blood and urine tests. * Participants will have two imaging studies of the brain at separate study visits. The first study visit will involve a magnetic resonance imaging (MRI) scan to provide a baseline image of the brain. The second study visit will involve PET scan with the radioactive chemical (11C)PBR28 to study immune system proteins in the brain. The MRI scan will take about 40 minutes, and the PET scan will take about 2 hours. * Participants will have a final study visit 24 hours after the PET scan to provide a final blood sample for testing.

Key facts

Study ID

NCT01322555

Run by

National Institute of Mental Health (NIMH)

People needed

15

Starts

2011-03-04

Expected to finish

2017-07-14

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• PATIENTS WITH AUTISM OR ASD (EXCLUSION CRITERIA):
• Any history of alcohol or substance dependence, as these conditions may alter uptake of [11C]PBR28.
• Any history of alcohol or substance abuse within the past 6 months, as these conditions may alter uptake of [11C]PBR28.
• Schizophrenia.
• In addition to the diagnosis of autistic disorder, ASD or Asperger, any other Axis I disorder that requires inpatient hospitalization during this study, or is at the time of enrollment worsening relative to baseline. We will not completely exclude all Axis I disorders, because it is typical for patients with autism /ASD to carry comorbid Axis I disorders, including Generalized Anxiety Disorder (GAD), social phobia, obsessive compulsive disorder (OCD), dysthymia, Major Depressive Disorder.
• Intellectual quotient (IQ) less than 30, as including the lowest functioning patients would make the experiment logistically challenging and would broaden heterogeneity too much.
• Clinically significant laboratory abnormalities as assessed by the PI, medically responsible investigator or consultant.
• Serious medical problems including but not limited to chronic neurological disease such as multiple sclerosis, autoimmune diseases, poorly controlled seizure disorder, or serious cardiopulmonary disease.
• Active seizure disorder, as defined as having had a seizure in the past year or being on antiepileptic medications for seizures.
• Positive HIV status.
• Head trauma resulting in a period of unconsciousness lasting longer than 5 minutes.
• Exposure to radiation in the past year (i.e., PET from other research), which when combined with this study would be above the allowable limits.
• Positive urine drug screen at time of enrollment.
• Pregnancy at time of scan (beta HCG will be measured in all female patients within 24 hours before start of scan and must be negative).
• In patients who will get an MRI scan at NIH, metallic foreign bodies that would be affected by the MRI magnet, or a fear of enclosed spaces that would prohibit MRI scanning.
• Allergy to propofol or eggs (since egg products are used to formulate propofol),.
• Snoring, as this increases the likelihood of complications from propofol sedation.
• Currently taking antibacterial drugs (such as Amoxicillin-Clavulanate/ Augmentin , Metronidazole/Flagyl Minocycline/Minocin ). We will not discontinue any medications in any subjects.
• Currently taking antiviral drugs (such as Acyclovir/Zovirax , Interferon beta 1/Avonex , Valacyclovir/Valtrex ). We will not discontinue any medications in any subjects.
• Taking corticosteroids within the 6 months prior to study enrollment (such as Dexamethasone/Decadron , Hydrocortisone/Hydrocortone , Methylprednisone/Medrol ). We will not discontinue any medications in any subjects.
• Taking immunosuppressants in the past 6 months prior to study enrollment (such as Azathioprine/Imuran , Infliximab/Remicade , Sulfasalazine/ Azulfidine , Olsalazine/Dipentum ). We will not discontinue any medications in any subjects.
• Any history of taking immunosuppressants in the context of chemotherapy or organ transplant. Medications in this class might include Tacrolimus/Prograf , 6-mercaptopurine/Purinethol , and Methotrexate/Trexall . We will not discontinue any medications in any subjects.
• Currently taking Clozapine/Clozaril , as high doses in rats increases TSPO. With the exception of clozapine, patients may be on centrally-acting medications, including medications for mood and behavioral disturbances. These medications may be antiepileptic medications, so long as the antiepileptics are being used for symptoms of mood and behavior as opposed to seizure disorder.
• Healthy Volunteers (Exclusion criteria):
• Any past or present Axis I disorder. The exception is substance abuse which ended over 6 months prior to enrollment.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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