Autism
Conditions
Keywords
Autism, Nicotinic agonist, Cognition, P50, Alpha 7
Brief summary
This study plans to learn more about whether a nicotine-like investigational new drug, DMXB-A \[3-(2,4-dimethoxybenzylidene) anabaseine\] may have positive effects on mental focus and may help us to find new types of treatment for autism spectrum disorder. Subjects will come in for a screening visit and three more drug visits. There will be at least one week between each drug visit to allow the drug to be eliminated from your system completely. During each drug visit subjects will receive either a placebo (a capsule that looks like medicine but is not real), 75 mg of DMXB-A, or 150 mg of DMXB-A. During the drug day vital signs and well being will be monitored by the study physician. Subjects will complete some paper and pencil tasks to test memory, attention, speed, and problem solving, some rating scales and questionnaires, and the study team will record brain wave patterns with an electroencephalogram (EEG) .
Interventions
DRUGDMXB-A 150 mg
OTHERplacebo
DRUGDMXB-A 75 mg
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* age 18-50 * meet DSM-5 criteria for Autism Spectrum Disorder, Levels 1 or 2, as defined by Autism Diagnostic Observation Schedule * non-smoking persons * in good health
Exclusion criteria
* persons with estimated verbal and nonverbal IQ \< 70. * abuse of other substances. * Persons not sufficiently fluent in English to permit testing * those with history of severe head injury * Fragile X Syndrome * Rett Syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration | 2 hours after drug administration |
| Difference between drug and placebo on the CPT at 30 minutes after administration | 30 minutes after drug administration |
| Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration | 1 hour after drug administration |
| Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration | 2 hours after drug administration |
Countries
United States
Outcome results
None listed