This multi-center, randomized double-blind, placebo-controlled study will 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 placebo. Anticipated time on study treatment is 38 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Aurora, Colorado, United States
Safety: Incidence of adverse events
Time frame: 16 weeks
Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests
Time frame: 5-6 weeks
Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC)
Time frame: 5-6 weeks
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Unnamed facility
Decatur, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
London, United Kingdom