Trials / Terminated
TerminatedNCT04308954
Neuroimaging GABA Physiology in Fragile X Syndrome
Cross-Species Multi-Modal Neuroimaging to Investigate GABA Physiology in Fragile X Syndrome
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- Male
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Not accepted
Summary
The investigators wish to compare the brain distribution of GABA(A) receptors and GABA levels in young adult males with Fragile X Syndrome compared to idiopathic intellectual developmental disorder. The radiopharmaceutical \[18F\]flumazenil has been used to study GABA(A) receptor distribution in other genetic syndromes with autistic features; however, despite overwhelming evidence supporting the importance of the GABAergic system in FXS, no clinical investigation of this system in human FXS has been reported in the literature. Therefore, this study will provide the first in vivo comprehensive examination of the GABAergic system in FXS using hybrid positron emission tomography/ magnetic resonance imaging (PET/MRI).
Detailed description
Fragile X syndrome (FXS) is the most common genetic cause of autism spectrum disorder (ASD). Converging evidence suggests that GABAergic dysfunction occurs in FXS. The investigators wish to examine brain distribution of GABA (A) receptors in young adult males with FXS using hybrid PET/MRI with \[18F\]flumazenil. This project will study the distribution of GABA(A) receptors in 15 young male adults with FXS (18-30 years old) compared to 15 age-matched male subjects with idiopathic intellectual developmental disorder (IDD) as controls. Simultaneous PET/MRI acquisition is an optimal technique to study in vivo GABAergic dysfunction and GABAa receptor distribution.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [18F]flumazenil | \[18F\]flumazenil is a PET radiopharmaceutical that can be used to determine gamma-aminobutyric acid (GABA(A)) receptor density. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2018-12-06
- Completion
- 2018-12-06
- First posted
- 2020-03-16
- Last updated
- 2021-01-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04308954. Inclusion in this directory is not an endorsement.