A Study of RG1662 in Individuals With Down Syndrome

A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Investigate Safety and Tolerability of RG1662 in Individuals With Down Syndrome

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01436955

Enrollment

Registered

2011-09-20

Start date

2011-11-30

Completion date

2013-09-30

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

Brief summary

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.

Interventions

DRUGPlacebo

multiple oral doses

DRUGRG1662

Cohorts receiving multiple oral doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

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

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	16 weeks

Secondary

Measure	Time frame
Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests	5-6 weeks
Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC)	5-6 weeks

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026