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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
13
Unnamed facility
London, United Kingdom
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
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
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