A Study of RG1662 in Individuals With Down Syndrome



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 30
Updated:11/23/2013
Start Date:November 2011
End Date:September 2013
Contact:Reference Study ID Number: BP25543 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. Only)

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


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.


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
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