Efficacy of Bumetanide to Improve Cognitive Functions in Down Syndrome

"Patients in the Bumetanide group will be treated for 3 months with a dose of 0.02 mg/kg twice a day, oral administration. It will be labeled (pre-printed and indistinguishable) with the randomization number and site number and will be delivered in separate blocks during the first, second and fourth appointment.~The patients will start the treatment with half of the full target dose during the first week:~* If the target dose is 0.5mg BID, only the morning dose will be administrated.~* If the target dose is 1.0 mg BID the dose will be 0.5 mg BID.~* If the target dose is 1.5mg BID, the morning dose will be 1.0 mg, the evening dose will be 0.5 mg.~* If the target dose is 2.0 mg BID the dose will be 1.0 mg BID The patient will continue with the full dose starting from Visit 2 after 1 week of dosing."

Patients in the control (placebo) group will be given placebo for 3 months twice a day, oral administration. The Placebo tablets will be visually indistinguishable from Bumetanide and packaged as Bumetanide. The placebo will be labeled (pre-printed and indistinguishable) with the randomisation number and site number and will be delivered in separate blocks during the first, second and fourth visits.