Alzheimer's Disease Education and Referral Center

RG1662 in Individuals with Down Syndrome

RG1662 in Individuals with Down Syndrome

Overall Status: 
Completed
Brief Description: 

The purpose of this study is to assess the safety and tolerability of the experimental drug RG1662 in individuals with Down syndrome.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
18 Years
30 Years
Both
No
Inclusion Criteria: 

  • Males and nonpregnant, nonlactating females with a diagnosis of Down syndrome (confirmed by karyotype)
  • Parent or legal guardian/representative and caregiver willing to give written informed consent
  • Subject willing and consenting to participate

Exclusion Criteria: 

  • Major depressive disorder not adequately controlled by a selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor
  • Clinical diagnosis of autistic spectrum disorder or attention deficit or hyperactivity disorder that makes study participation unlikely
  • Other primary psychiatric diagnosis
  • Evidence or clinical diagnosis of dementia
  • Personal history of cardiac abnormalities; patients that have previously undergone congenital heart surgery can be enrolled provided they have no residual complication requiring intervention (e.g., pacemaker)
  • Clinically significant obstructive pulmonary disease or asthma that is not adequately treated (oral steroids are not allowed)
  • Thyroid dysfunction that is not adequately controlled and stabilized on treatment for at least 8 weeks
  • Sustained elevated supine blood pressure exceeding 140/90 mmHg or notable resting tachycardia or blood pressure below 90/40 mmHg
  • Have taken any other investigational medications within past 3 months
  • Body mass index (BMI) of more than 40 kg/m2

Detailed Description: 

The purpose of this study is to assess the safety and tolerability of RG1662 in individuals with Down syndrome. Eligible subjects will be randomized in cohorts to receive either multiple oral doses of RG1662 or a placebo. Anticipated time on study treatment is 38 days. RG1662 is an agonist of the GABA A receptor, a major inhibitory gateway in the brain.

Central Contact Information: 

For more information about this trial and its study sites, please call 1-888-662-6728 (U.S. only) or email genentechclinicaltrials@druginfo.com. Reference study ID number BP25543.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.8092255, -84.2805478

Site
Decatur
Georgia
30033
Name:
Phone:

Geolocation is 34.7179437, -92.3714901

Site
Little Rock
Arkansas
72204
Name:
Phone:

Geolocation is 32.8328112, -117.2712717

Site
La Jolla
California
92037
Name:
Phone:

Geolocation is 39.7503186, -104.8367063

Site
Aurora
Colorado
80045
Name:
Phone:

Geolocation is 41.8816606, -87.6926257

Site
Chicago
Illinois
60612
Name:
Phone:

Geolocation is 39.2962372, -76.5928888

Site
Baltimore
Maryland
21287
Name:
Phone:

Geolocation is 36.0038131, -78.9387241

Site
Durham
North Carolina
27710
Name:
Phone:

Geolocation is 33.5080943, -112.0863874

Site
Phoenix
Arizona
85013
Name:
Phone:
Lead Sponsor: 
Agency
Hoffmann-La Roche
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Clinical Trials
Study Director
Hoffmann-La Roche
Study Contact: 
NamePhoneEmail
Genentech Clinical Trials Information
888-662-6728 (U.S. only)
Locations
 
 
ClinicalTrials.gov ID 
Official Title: 
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Investigate Safety and Tolerability of RG1662 in Individuals With Down Syndrome
Study Start Date: 
November 2011
Study End Date: 
July 2013
Disease Stage: 
Pre-clinical
Enrollment: 
33