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Clinical Trials/NCT01451983
NCT01451983
Completed
N/A

Genetic, Biochemical, Behavioral and Neuroimaging Phenotypes of Autism Spectrum Disorders (ASDs)

The Cleveland Clinic1 site in 1 country138 target enrollmentMay 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorders
Sponsor
The Cleveland Clinic
Enrollment
138
Locations
1
Primary Endpoint
Total Brain Volume
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this research is to better understand the genetic, biochemical, cognitive and behavioral symptom abnormalities that contribute to autism spectrum disorders. The investigators anticipate recruiting at least 100 participants with autism spectrum disorder and large head size, at least 100 participants with autism spectrum disorder without large head size and at least 40 healthy siblings. Biological parents are expected to be recruited only as genetic changes are identified in individuals with autism spectrum disorders to better understand the nature of these genetic changes. Participants are asked to complete cognitive testing, a blood draw, urine collection and measurement of his/her height, weight and head circumference. Parents or caregivers may be asked to complete a diagnostic evaluation and will complete questionnaires that examine the participant's medical and family history as well as his/her current symptoms, functioning, and quality of life. A brief report simply listing and giving a basic description of any behavioral diagnostic information, autism symptoms, adaptive functioning, and a listing of results from cognitive testing will be provided as part of this study.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
August 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas W. Frazier, Ph.D

Autism Research Program Director

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of autism
  • Consent from parents or guardians or an adult with or suspected of having an autism spectrum disorder that does not require a legal guardian or an adult who is the healthy sibling of an individual with an autism spectrum disorder.
  • Youth ages 2-17 and adults ages 18-
  • Youths and adults who are able (some young or severely impaired participants may not be able to provide assent) will be asked to provide assent.
  • Families with multiple children who meet the above inclusion criteria will be permitted to have as many children participate as they wish.
  • Youth ages 2-17 and adults ages 18-50 who do not have an autism spectrum disorder or are not suspected of having an autism spectrum disorder and who have a sibling with an autism spectrum disorder who has participated in the present study.

Exclusion Criteria

  • Clinically significant medical disease that would prohibit participation in the study procedures.
  • Children younger than 2 years old and adults older than 50 years old.

Outcomes

Primary Outcomes

Total Brain Volume

Time Frame: Baseline

Study Sites (1)

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