A Study of RG1662 in Individuals With Down Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

RG1662

Intervention Type DRUG

Cohorts receiving multiple oral doses

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

multiple oral doses

Interventions

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Placebo

multiple oral doses

Intervention Type DRUG

RG1662

Cohorts receiving multiple oral doses

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No