Rivastigmine Study in Adolescents With Down Syndrome

2014-08-27 03:15:18 | BioPortfolio


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.


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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Down Syndrome


Rivastigmine, Liquid Placebo


Kennedy Krieger Institute
United States




Duke University

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:18-0400

Clinical Trials [1352 Associated Clinical Trials listed on BioPortfolio]

Efficacy of Rivastigmine in Patients With Down Syndrome

This study is to understand the efficacy on language and cognitive function in Down syndrome patients who take Rivastigmine.

RIVastigmine In Vascular cognitivE Impairment

The study is a 24-week prospective, double blind, randomized, placebo-controlled pilot study of 9 mg / day Rivastigmine in patients with Vascular Cognitive Impairment Not Dementia (CIND) t...

Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment

This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in ri...

Rivastigmine as a Treatment for Methamphetamine Dependence

To study the effects of treatment with rivastigmine on craving produced by experimental administration of methamphetamine.

Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment

This study will evaluate the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in cognitively impaired Multiple Sclerosis (MS) patients. Primary objective is the assessment of...

PubMed Articles [8513 Associated PubMed Articles listed on BioPortfolio]

Factors Associated With Response to Placebo in Patients With Irritable Bowel Syndrome and Constipation.

A high proportion of patients with irritable bowel syndrome (IBS) respond to placebo in clinical trials (estimated at about 40%). We aimed to identify factors that contribute to the high placebo respo...

Effect of cholinergic treatment depends on cholinergic integrity in early Alzheimer's disease.

In early Alzheimer's disease, which initially presents with progressive loss of short-term memory, neurodegeneration especially affects cholinergic neurons of the basal forebrain. Pharmacotherapy of A...

Melatonin Treatment in Patients with Burning Mouth Syndrome: A Triple-Blind, Placebo-Controlled, Crossover Randomized Clinical Trial.

To evaluate the efficacy of melatonin compared to placebo in reducing pain associated with burning mouth syndrome (BMS), as well as side effects of treatment and effects on sleep quality, anxiety, and...

A Randomized Double-Blind, Placebo-Controlled, Cross-Over Study Using Baclofen in the Treatment of Rumination Syndrome.

Both rumination syndrome and supra-gastric belching (SGB) have limited treatment options. We demonstrated (open-label) that baclofen reduces pressure flow events in these patients. We aimed to study t...

Assessing the impacts of total liquid ventilation on left ventricular diastolic function in a model of neonatal respiratory distress syndrome.

Filling the lung with dense liquid perfluorocarbons during total liquid ventilation (TLV) might compress the myocardium, a plausible explanation for the instability occasionally reported with this tec...

Medical and Biotech [MESH] Definitions

The removal of a soluble component from a liquid mixture by contact with a second liquid, immiscible with the carrier liquid, in which the component is preferentially soluble. (McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)

Miniaturized methods of liquid-liquid extraction.

A method of separation of two or more substances by repeated distribution between two immiscible liquid phases that move past each other in opposite directions. It is a form of liquid-liquid chromatography. (Stedman, 25th ed)

A carbamate-derived reversible CHOLINESTERASE INHIBITOR that is selective for the CENTRAL NERVOUS SYSTEM and is used for the treatment of DEMENTIA in ALZHEIMER DISEASE and PARKINSON DISEASE.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

More From BioPortfolio on "Rivastigmine Study in Adolescents With Down Syndrome"

Quick Search


Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Searches Linking to this Trial