A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667367
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Hoffmann-La Roche

August 14, 2012
August 17, 2012
September 2, 2015
August 2012
October 2013   (Final data collection date for primary outcome measure)
  • Brain GABAA receptor alpha5 subunit localization/density assessed by positron emission tomography (PET) [ Time Frame: approximately 1 day ]
  • Brain GABAA receptor alpha5 subunit occupancy following single dose of RG1662 [ Time Frame: approximately 1 day ]
  • Correlation of RG1662 plasma concentrations and GABAAalpha5 receptor occupancy [ Time Frame: approximately 12 months ]
Same as current
Complete list of historical versions of study NCT01667367 on Archive Site
  • Safety: Incidence of adverse events [ Time Frame: 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 ]
  • Functional brain connectivity of individuals with Down syndrome versus healthy controls receiving placebo [ Time Frame: approximately 12 months ]
Same as current
Not Provided
Not Provided
A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Healthy Volunteer, Down Syndrome
  • Drug: RG1662
    Single oral dose
  • Drug: placebo
    Single oral dose
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: RG1662
    Intervention: Drug: RG1662
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2013
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
2012-001301-24 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP