A Study of RG1662 in Individuals With Down Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 10 June 2013
• Main ID: NCT01436955
• Date of registration: 18/08/2011
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of RG1662 in Individuals With Down Syndrome
• Scientific title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Investigate Safety and Tolerability of RG1662 in Individuals With Down Syndrome
• Date of first enrolment: January 2012
• Target sample size: 33
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01436955
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United Kingdom, United States

Contacts

• Name: Reference Study ID Number: BP25543 www.roche.com/about_roche/roche_worldwide.htm

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 30 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Down Syndrome

Intervention(s)

Drug: Placebo

Drug: RG1662

Primary Outcome(s)

Safety: Incidence of adverse events [Time Frame: 16 weeks]

Secondary Outcome(s)

Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests [Time Frame: 5-6 weeks]

Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC) [Time Frame: 5-6 weeks]

Secondary ID(s)

BP25543

Source(s) of Monetary Support

Please refer to primary and secondary sponsors