CClinicalTrials.gg
Sign In
CompletedNCT01436955Updated Mar 3, 2015

A Study of RG1662 in Individuals With Down Syndrome

A Phase 1 interventional study of Placebo and RG1662 in Down Syndrome, sponsored by Hoffmann-La Roche. Completed at 9 sites in 2 countries. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2015-03-03.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Down Syndrome
03

In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's enrollment of 35 is close to the median of 36 across 283 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    A

    Drug: RG1662

  • Placebo comparator
    B

    Drug: Placebo

Interventions

  • DrugPlacebo

    multiple oral doses

  • DrugRG1662

    Cohorts receiving multiple oral doses

06

What researchers measure

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

07

Study locations

9 sites
  • Phoenix, Arizona 85013, United States
  • Little Rock, Arkansas 72204, United States
  • La Jolla, California 92037, United States
  • Aurora, Colorado 80045, United States
  • Decatur, Georgia 30033, United States
  • Chicago, Illinois 60612, United States
  • Baltimore, Maryland 21287, United States
  • Durham, North Carolina 27710, United States
  • London, NW10 7EW, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01436955
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 20, 2011
Start date
Nov 2011
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Mar 3, 2015

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Down Syndrome→

Other studies from this sponsor

Hoffmann-La Roche

Start the discussion