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12 Mechanisms of Action

||||||||||  basmisanil (RG1662) / Roche
Trial primary completion date:  A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS) (clinicaltrials.gov) -  May 13, 2014
P2, N=180, Recruiting,  Sponsor: Hoffmann-La Roche
Trial primary completion date: Jan 2016 --> Aug 2015

||||||||||  basmisanil (RG1662) / Roche
Trial initiation date:  A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS) (clinicaltrials.gov) -  May 13, 2014
P2, N=180, Recruiting,  Sponsor: Hoffmann-La Roche
Trial primary completion date: Jan 2016 --> Aug 2015 Initiation date: Mar 2014 --> May 2014

||||||||||  basmisanil (RG1662) / Roche
Trial completion date:  A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS) (clinicaltrials.gov) -  May 13, 2014
P2, N=180, Recruiting,  Sponsor: Hoffmann-La Roche
Initiation date: Mar 2014 --> May 2014 Trial completion date: Jan 2016 --> Aug 2015

||||||||||  basmisanil (RG1662) / Roche
Enrollment open:  A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS) (clinicaltrials.gov) -  May 13, 2014
P2, N=180, Recruiting,  Sponsor: Hoffmann-La Roche
Trial completion date: Jan 2016 --> Aug 2015 Not yet recruiting --> Recruiting

||||||||||  basmisanil (RG1662) / Roche
Trial initiation date:  A Study of RG1662 in Individuals With Down Syndrome (clinicaltrials.gov) -  May 11, 2014
P1, N=35, Completed,  Sponsor: Hoffmann-La Roche
Not yet recruiting --> Recruiting Initiation date: Jan 2012 --> Nov 2011

||||||||||  MK-2206 / Merck (MSD)
Enrollment change:  MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia (clinicaltrials.gov) -  Apr 27, 2014
P1, N=45, Completed,  Sponsor: National Cancer Institute (NCI)
Initiation date: Jan 2012 --> Nov 2011 N=96 --> 45

||||||||||  donepezil / Generic mfg.
New P2 trial:  A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living. (clinicaltrials.gov) -  Mar 19, 2014
P2, N=60, Recruiting,  Sponsor: Eisai Co., Ltd.

||||||||||  thioguanine / Generic mfg.
Trial completion:  Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome (clinicaltrials.gov) -  Feb 19, 2014
P3, N=254, Completed,  Sponsor: Children's Oncology Group
N=96 --> 45 No longer recruiting --> Completed

|||||||||| Trial completion: A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome (clinicaltrials.gov) - Feb 2, 2014
P=N/A, N=90, Completed, Sponsor: Hoffmann-La Roche
No longer recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Synagis (palivizumab) / AbbVie, AstraZeneca, SOBI
Enrollment open:  Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immuno Compromised Children With Synagis (clinicaltrials.gov) -  Jan 27, 2014
P=N/A, N=250, Recruiting,  Sponsor: AbbVie
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Trial initiation date: Intensive Dysarthria Sessions in Adults and Children With Down Syndrome (clinicaltrials.gov) - Jan 23, 2014
P=N/A, N=12, Not yet recruiting, Sponsor: Duke University
Not yet recruiting --> Recruiting Initiation date: Aug 2013 --> Jan 2014

|||||||||| Enrollment closed: Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies (clinicaltrials.gov) - Jan 15, 2014
P=N/A, N=3000, Active, not recruiting, Sponsor: Sequenom, Inc.
Initiation date: Aug 2013 --> Jan 2014 Recruiting --> Active, not recruiting

||||||||||  rivastigmine / Generic mfg.
Enrollment closed:  DS-Riv: Rivastigmine Study in Adolescents With Down Syndrome (clinicaltrials.gov) -  Jan 15, 2014
P1/2, N=40, Active, not recruiting,  Sponsor: Duke University
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

|||||||||| Enrollment change: SEQ21: Trisomy of Chromosome 21 Diagnosis by High Output Sequencing (clinicaltrials.gov) - Jan 1, 2014
P=N/A, N=976, Completed, Sponsor: Assistance Publique - Hôpitaux de Paris
Recruiting --> Active, not recruiting N=255 --> 976

|||||||||| Trial completion: SEQ21: Trisomy of Chromosome 21 Diagnosis by High Output Sequencing (clinicaltrials.gov) - Jan 1, 2014
P=N/A, N=976, Completed, Sponsor: Assistance Publique - Hôpitaux de Paris
N=255 --> 976 Recruiting --> Completed

||||||||||  basmisanil (RG1662) / Roche
New P2 trial:  A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS) (clinicaltrials.gov) -  Dec 29, 2013
P2, N=180, Not yet recruiting,  Sponsor: Hoffmann-La Roche

||||||||||  basmisanil (RG1662) / Roche
Trial completion:  A Study of RG1662 in Individuals With Down Syndrome (clinicaltrials.gov) -  Nov 12, 2013
P1, N=35, Completed,  Sponsor: Hoffmann-La Roche
Recruiting --> Completed Recruiting --> Completed

|||||||||| Trial initiation date: Study of the Efficacy of New Non-invasive Prenatal Tests for Screening for Fetal Trisomies Using Maternal Blood (clinicaltrials.gov) - Nov 6, 2013
P=N/A, N=5600, Recruiting, Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec
Recruiting --> Completed Initiation date: Aug 2013 --> Nov 2013

|||||||||| Enrollment open: Study of the Efficacy of New Non-invasive Prenatal Tests for Screening for Fetal Trisomies Using Maternal Blood (clinicaltrials.gov) - Nov 6, 2013
P=N/A, N=5600, Recruiting, Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec
Initiation date: Aug 2013 --> Nov 2013 Not yet recruiting --> Recruiting

||||||||||  basmisanil (RG1662) / Roche
Enrollment change:  A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662 (clinicaltrials.gov) -  Nov 4, 2013
P1, N=13, Completed,  Sponsor: Hoffmann-La Roche
Not yet recruiting --> Recruiting N=17 --> 13

||||||||||  basmisanil (RG1662) / Roche
Trial completion:  A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662 (clinicaltrials.gov) -  Nov 4, 2013
P1, N=13, Completed,  Sponsor: Hoffmann-La Roche
N=17 --> 13 Recruiting --> Completed

||||||||||  basmisanil (RG1662) / Roche
Enrollment open:  A Screening Protocol to Assess Adults and Adolescents With Down Syndrome for Eligibility For Upcoming Study of RG1662 (Study BP27832) (clinicaltrials.gov) -  Oct 6, 2013
P=N/A, N=170, Recruiting,  Sponsor: Hoffmann-La Roche
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  MK-2206 / Merck (MSD)
Trial completion:  MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia (clinicaltrials.gov) -  Sep 26, 2013
P1, N=45, Completed,  Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  cytarabine / Generic mfg.
Enrollment change:  Low-Dose Cytarabine in Treating Infants With Down Syndrome and Transient Myeloproliferative Disorder (clinicaltrials.gov) -  Aug 21, 2013
P3, N=0, Withdrawn,  Sponsor: Children's Oncology Group
Active, not recruiting --> Completed N=180 --> 0

|||||||||| Enrollment change: Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia (clinicaltrials.gov) - Aug 20, 2013
P3, N=25, Active, not recruiting, Sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
N=180 --> 0 N=280 --> 25

|||||||||| Enrollment change: Non-invasive Chromosomal Examination of Trisomy Study (clinicaltrials.gov) - Aug 14, 2013
P=N/A, N=18955, Active, not recruiting, Sponsor: Ariosa Diagnostics, Inc
N=280 --> 25 N=25000 --> 18955

|||||||||| Enrollment closed: Non-invasive Chromosomal Examination of Trisomy Study (clinicaltrials.gov) - Aug 14, 2013
P=N/A, N=18955, Active, not recruiting, Sponsor: Ariosa Diagnostics, Inc
N=25000 --> 18955 Recruiting --> Active, not recruiting

|||||||||| Trial completion: Comparison of Aneuploidy Risk Evaluations (clinicaltrials.gov) - Jul 11, 2013
P=N/A, N=3000, Completed, Sponsor: Verinata Health, Inc.
Recruiting --> Active, not recruiting Recruiting --> Completed

|||||||||| Enrollment change: Non-invasive Prenatal Diagnostic Validation Study (clinicaltrials.gov) - Jun 27, 2013
P=N/A, N=1781, Completed, Sponsor: Natera, Inc.
Recruiting --> Completed N=4640 --> 1781

|||||||||| Trial completion: Non-invasive Prenatal Diagnostic Validation Study (clinicaltrials.gov) - Jun 27, 2013
P=N/A, N=1781, Completed, Sponsor: Natera, Inc.
N=4640 --> 1781 Recruiting --> Completed

||||||||||  thioguanine / Generic mfg.
Enrollment change:  Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome (clinicaltrials.gov) -  Jun 25, 2013
P3, N=254, Completed,  Sponsor: Children's Oncology Group
Recruiting --> Completed N=158 --> 254

|||||||||| Enrollment change: Assessment of Bone Density and Bone Turnover Markers in Patients With Down Syndrome and Comparison to the Ts65Dn Model (clinicaltrials.gov) - Jun 18, 2013
P=N/A, N=60, Active, not recruiting, Sponsor: University of Arkansas
N=158 --> 254 N=30 --> 60

|||||||||| Clinical: Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome (clinicaltrials.gov) - Mar 7, 2013
P=N/A, N=87, Recruiting, Sponsor: Children's Hospital of Philadelphia

|||||||||| Enrollment change: Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes (clinicaltrials.gov) - Mar 4, 2013
P=N/A, N=511, Completed, Sponsor: University of California, Davis
N=30 --> 60 N=320 --> 511

|||||||||| Trial completion: Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes (clinicaltrials.gov) - Mar 4, 2013
P=N/A, N=511, Completed, Sponsor: University of California, Davis
N=320 --> 511 Recruiting --> Completed

|||||||||| Trial completion: Efficacy and Safety of Memantine Hydrochloride in Enhancing the Cognitive Abilities of Young Adults With Down Syndrome (clinicaltrials.gov) - Dec 25, 2012
P4, N=42, Completed, Sponsor: University of Colorado, Denver
Recruiting --> Completed Recruiting --> Completed

||||||||||  rivastigmine / Generic mfg.
Enrollment change:  Efficacy of Rivastigmine in Patients With Down Syndrome (clinicaltrials.gov) -  Nov 26, 2012
P=N/A, N=14, Completed,  Sponsor: National Taiwan University Hospital
Recruiting --> Completed N=20 --> 14

||||||||||  rivastigmine / Generic mfg.
Trial completion:  Efficacy of Rivastigmine in Patients With Down Syndrome (clinicaltrials.gov) -  Nov 26, 2012
P=N/A, N=14, Completed,  Sponsor: National Taiwan University Hospital
N=20 --> 14 Recruiting --> Completed

|||||||||| Enrollment change: Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies (clinicaltrials.gov) - Nov 25, 2012
P=N/A, N=3000, Active, not recruiting, Sponsor: Sequenom, Inc.
Recruiting --> Completed N=1600 --> 3000

|||||||||| New P2 trial: Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool (clinicaltrials.gov) - Oct 2, 2012
P2, N=100, Recruiting, Sponsor: Parc de Salut Mar

|||||||||| Clinical: Intensive Dysarthria Sessions in Adults and Children With Down Syndrome (clinicaltrials.gov) - Sep 11, 2012
P=N/A, N=12, Not yet recruiting, Sponsor: Duke University

|||||||||| Biomarker, Trial completion: Biomarkers in Samples From Patients With Down Syndrome and Acute Megakaryoblastic Leukemia (clinicaltrials.gov) - Sep 4, 2012
P=N/A, N=10, Completed, Sponsor: Children's Oncology Group
N=1600 --> 3000 Active, not recruiting --> Completed

||||||||||  basmisanil (RG1662) / Roche
New P1 trial:  A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662 (clinicaltrials.gov) -  Aug 15, 2012
P1, N=13, Completed,  Sponsor: Hoffmann-La Roche

|||||||||| Enrollment change: Detecting Early Onset Pre-eclampsia and Use of Placental Growth Factor (PlGF) for Marker of Trisomy 21 (clinicaltrials.gov) - Jun 18, 2012
P=N/A, N=2000, Recruiting, Sponsor: OVO R & D
Active, not recruiting --> Completed N=5000 --> 2000

|||||||||| Trial termination, Biopsy: Preimplantation Genetic Diagnosis (PGD) by Array Comparative Genome Hybridization (CGH) and Blastocyst Biopsy (clinicaltrials.gov) - May 24, 2012
P3, N=120, Terminated, Sponsor: Reprogenetics
N=5000 --> 2000 Recruiting --> Terminated; Not enough patients enrolling

|||||||||| Clinical: Gait in Children With Down Syndrome While Wearing Orthoses (clinicaltrials.gov) - May 13, 2012
P=N/A, N=6, Completed, Sponsor: University of Puget Sound

|||||||||| New P3 trial: Multicenter Vitamin E Trial in Aging Persons With Down Syndrome (clinicaltrials.gov) - May 7, 2012
P3, N=349, Completed, Sponsor: New York State Institute for Basic Research

|||||||||| Enrollment open: Detecting Early Onset Pre-eclampsia and Use of Placental Growth Factor (PlGF) for Marker of Trisomy 21 (clinicaltrials.gov) - Apr 22, 2012
P=N/A, N=2000, Recruiting, Sponsor: OVO R & D
Recruiting --> Terminated; Not enough patients enrolling Not yet recruiting --> Recruiting

|||||||||| Enrollment open: Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies (clinicaltrials.gov) - Mar 21, 2012
P=N/A, N=2200, Recruiting, Sponsor: Sequenom, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

|||||||||| Enrollment change: IMMUTRI: Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome (clinicaltrials.gov) - Mar 20, 2012
P=N/A, N=72, Completed, Sponsor: Institut Jerome Lejeune
Not yet recruiting --> Recruiting N=60 --> 72