EUCTR2008-003287-18-BE
Active, not recruiting
Not Applicable
Functional consequences of decreased RNA expression of certain GABA(A) receptor subunits in fragile X patients using Positron Emission Tomography and [11C]flumazenil. - PET-FRAX-GABA
niversity Antwerp0 sitesSeptember 3, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fragile X syndrome is the most common form of inherited mental retardation with a prevalence of 1/4000 males and 1/6000 females. Patients are characterized by a mild to severe form of cognitive impairment and light dysmorphic features. Autism-like behaviour, hyperactivity and epilepsy can also be associated with the disease. On the molecular level the disease is caused by a dynamic mutation of a CGG repeat in the 5' UTR of the FMR1 gene.
- Sponsor
- niversity Antwerp
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males between 18\-50 years old, general good health after physical examination and routine laboratory analysis, normal T1 and T2 brain MRI, body weight.
- •Males between 16\-50 years old, need to be approved by the investigators to undergo a 60 minutes PET imaging study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Controls and patients:
- •Drug abuse, hypersensitivity to drugs or flumazenil or benzodiazepines.
- •No history of other neurological or psychiatric abnormalities or any other major internal abnormality.
- •Medication which interacts with the GABA\-system, in particular sleep enhancing medication, is not allowed within two weeks before and after the study, neither
- •drinking more than 3 caffein\-containing glasses.
- •Current smokers (more than 5 sigarettes per day) and smokers who quitted less than three months ago will be excluded.
- •Alcohol is prohibited as from 2 days before the beginning of the study.
Outcomes
Primary Outcomes
Not specified
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