A Study of RG1662 in Individuals With Down Syndrome

Roche

Status and phase

Completed

Phase 1

Conditions

Down Syndrome

Treatments

Drug: Placebo

Drug: RG1662

Study type

Interventional

Funder types

Industry

Identifiers

NCT01436955

BP25543

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult individuals, 18 to 30 years of age, with diagnosis of Down Syndrome (confirmed by karyotype)
Males and non-pregnant non-lactating females
Parent or legal guardian/representative and caregiver willing to give written informed consent
Subject willing and assenting or consenting to participate

Exclusion criteria

Major depressive disorder not adequately controlled by a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor
Subjects meeting clinical diagnostic criteria for autistic spectrum disorder, attention deficit or hyperactivity disorder unlikely to cooperate and take part successfully in the study assessments
Subjects with other primary psychiatric diagnosis
Subjects with evidence or meeting clinical diagnosis of dementia
Subjects with 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. pace maker)
Subjects with clinically significant obstructive pulmonary disease or asthma that is not adequately treated (oral steroids are not allowed)
Subjects with thyroid dysfunction that is not adequately controlled and stabilized on treatment for at least 8 weeks
Subjects with sustained elevated supine blood pressure (SBP/DBP) at rest exceeding 140/90 mmHg or notable resting tachycardia (mean HR > 60 bpm) or blood pressure below 90/40 mmHg
Subjects who have taken any other investigational medications within 3 months
Body mass index (BMI) > 40 kg/m2