Rivastigmine Study in Adolescents With Down Syndrome (DS Riv)
This study is currently recruiting participants.
Verified March 2012 by Duke University
First Received on March 8, 2010. Last Updated on March 20, 2012 History of Changes
| Sponsor: | Duke University |
|---|---|
| Collaborator: | Taishoff Family Foundation |
| Information provided by (Responsible Party): | Duke University |
| ClinicalTrials.gov Identifier: | NCT01084135 |
Purpose
The purpose of this study is to determine if short term use of rivastigmine can improve functional abilities (for example, language, memory, and executive function) in adolescents with Down syndrome.
| Condition | Intervention | Phase |
|---|---|---|
| Down Syndrome | Drug: Rivastigmine Other: Liquid Placebo | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A 20-Week Double-Blind Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Rivastigmine in Children (Ages 10-18) With Down Syndrome |
Resource links provided by NLM:
MedlinePlus related topics: Down Syndrome
U.S. FDA Resources
Further study details as provided by Duke University:
Primary Outcome Measures:
- Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) [ Time Frame: Baseline & Study termination (Week 20) ] [ Designated as safety issue: No ]Indirect (parent report) measure of adaptive function
Secondary Outcome Measures:
- Behavior Rating Inventory of Executive Function-Preschool (Brief-P) [ Time Frame: Baseline and Final (Week 20) visit ] [ Designated as safety issue: No ]Indirect measure of executive function
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rivastigmine- Liquid form
At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
| Drug: Rivastigmine
At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. Subjects receiving placebo will maintain the same schedule. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose,down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
Other Name: Rivastigmine-Excelon
|
| Placebo Comparator: Liquid placebo
Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
| Other: Liquid Placebo
Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
|
Detailed Description:
This 24 week, double-blind, placebo controlled trial will be completed at the Clinical Research Unit of Duke University Medical Center and at the Kennedy Krieger Institute (KKI). Sixteen evaluable subjects will be enrolled at Duke and 24 evaluable subjects will be enrolled at KKI. The study consists of four visits, a screening visit (-4 weeks), a baseline visit (week 0); a safety visit at week 10, and a final/termination visit at week 20.
The specific aims of this study are to: a) investigate efficacy of rivastigmine tartrate treatment; b) build upon our open-label treatment results of overall function and language improvement in adolescents with Down syndrome (DS) in a double-blind, placebo-controlled clinical trial; and c) investigate other specific cognitive domains that may selectively respond to rivastigmine tartrate treatment.
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Correct VERBAL responses for 7/9 of the Expressive One Word Picture Vocabulary Test items.
- Subject able to put at least 2-3 words together in conversational speech.
- Subject's speech is understandable to the examiner for the majority of the time.
- Subjects are in good health and medically stable
Exclusion Criteria:
- Subject uses sign language as a primary means of communication
- Subject has a medical history that contraindicate the use of rivastigmine (For example, patients with active seizure disorders, asthma, celiac disease, heart disease or heart rhythm disorders).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084135
Contacts
| Contact: Jane Ann McKillop, MS, CGC | 919-668-4576 | janeann.mckillop@duke.edu |
| Contact: Blythe Crissman, MS, CGC | 919-681-1976 | criss004@mc.duke.edu |
Locations
| United States, Maryland | |
| Kennedy Krieger Institute | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Cathleen Weadon, BA 410-923-9140 weadon@kennedykrieger.org | |
| Principal Investigator: George Capone, MD | |
Sponsors and Collaborators
Duke University
Taishoff Family Foundation
Investigators
| Principal Investigator: | Priya Kishnani, MD | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01084135 History of Changes |
| Other Study ID Numbers: | Pro00013682 |
| Study First Received: | March 8, 2010 |
| Last Updated: | March 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
| Clinical trial Down syndrome adolescents cognitive rivastigmine |
Additional relevant MeSH terms:
| Down Syndrome Mental Retardation Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Rivastigmine Cholinesterase Inhibitors | Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 24, 2012
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