- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01667367
A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662
September 1, 2015 updated by: Hoffmann-La Roche
A Single-center, Single Blind Molecular and Functional Imaging Study to Assess GABAAalpha5 Receptor Expression, Occupancy and Functional Connectivity in the Brains of Individuals With Down Syndrome and Healthy Controls Following a Single Oral Administration of RG1662 or Placebo
This single-center, single-blind, placebo-controlled, parallel-group study with crossover component will evaluate the GABAAalpha5 receptor expression, occupancy and functional connectivity in the brains of individuals with Down syndrome and healthy controls following single dose RG1662.
Participants will receive a single dose of placebo before the imaging session (PET and MRI), and a single dose of RG1662 before the second imaging session.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, NW10 7EW
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Healthy controls and individuals with Down syndrome:
- Male and female adults, 18 to 40 years of age
- Body mass index (BMI) 18 - 40 kg/m2 inclusive
- Females of child-bearing potential and males with female partners of child-bearing potential must agree to use two medically approved methods of contraception, one of which must be a barrier method, for the duration of the study and for 4 months after the last study drug administration
- Clinical laboratory values within normal limits or abnormalities considered not significant by the investigator and sponsor; individuals with thyroid disease may be included in the study provided they are euthyroid and stable on treatment for at least one month prior to screening
Individuals with Down syndrome must also meet the following:
- Diagnosis of Down syndrome confirmed by karyotype; subjects may have free trisomy 21 or Robertsonian translocations; mosaic Down syndrome will be excluded
- Individuals must have a parent or other reliable caregiver who agrees to accompany the inidvidual to all clinic visits, provide information about the individual as required by protocol, and be willing to give informed consent
Exclusion Criteria:
- Regular smoker (>5 cigarettes or equivalent: 3 cigars, 6 cigarillos, 3 pipes per day)
- Concomitant disease or condition or any clinically significant finding at screening that could interfere with, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Severe head trauma or CNS infections (e.g. meningitis)
- History of epilepsy or seizures other than benign febrile convulsions of childhood
- Any confirmed significant allergic reactions against any drug, anaphylaxis or severe environmental allergies as judged by the investigator
- Positive for hepatitis B, hepatitis C or HIV infection
- Positive urine test at screening or at follow-up for drugs of abuse, or positive alcohol breath test at screening and prior to dosing
- Previous inclusion in research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (as defined by protocol)
- Pregnant or lactating women
- Individuals with evidence or meeting clinical diagnosis of dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Single oral dose
|
Experimental: RG1662
|
Single oral dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brain GABAA receptor alpha5 subunit localization/density assessed by positron emission tomography (PET)
Time Frame: approximately 1 day
|
approximately 1 day
|
Brain GABAA receptor alpha5 subunit occupancy following single dose of RG1662
Time Frame: approximately 1 day
|
approximately 1 day
|
Correlation of RG1662 plasma concentrations and GABAAalpha5 receptor occupancy
Time Frame: approximately 12 months
|
approximately 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: Incidence of adverse events
Time Frame: approximately 12 months
|
approximately 12 months
|
Resting state functional brain connectivity following a single dose of either RG1662 or placebo, assessed by functional magnetic resonance imaging (fMRI)
Time Frame: approximately 1 day
|
approximately 1 day
|
Functional brain connectivity of individuals with Down syndrome versus healthy controls receiving placebo
Time Frame: approximately 12 months
|
approximately 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
August 14, 2012
First Submitted That Met QC Criteria
August 15, 2012
First Posted (Estimate)
August 17, 2012
Study Record Updates
Last Update Posted (Estimate)
September 2, 2015
Last Update Submitted That Met QC Criteria
September 1, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP25611
- 2012-001301-24 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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