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NCT Number: NCT01436955

A Study 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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

multiple oral doses

RG1662

Drug

Cohorts receiving multiple oral doses

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 16 weeks

Secondary outcomes

  1. Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests

    Time frame: 5-6 weeks

  2. Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC)

    Time frame: 5-6 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 20, 2011
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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