Efficacy of Rivastigmine in Patients With Down Syndrome

NCT00748007 | Completed

• 1 other identifier: 200709028M
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Down Syndrome

Keywords

Down syndrome, cholinesterase inhibitor, Rivastigmine

Outcome Measures

Primary Outcomes (1)

• Scores of Vineland Adaptive Behavior Scales (VABS), Scores of WISC digit span, Scores of Leiter-R Forward memory , Scores of PPVT,

  at 24, and 54 weeks

Secondary Outcomes (1)

• Scores of NEPSY test for Visuospatial and Design Coping, Scores of Visuomotor Precision, Scores of WPPSI Sentences, Scores of Score for Character Recognitions by School Grade, and Scores of Test for Mathematic Ability for Children

  24 and 54 wks

Study Arms (2)

A

EXPERIMENTAL

Drug: Rivastigmine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Rivastigmine

Interventions

Rivastigmine DRUG

Exelon (1.5mg/cap) 1.5 mg bid

Also known as: Exelon and placebo, Cholinesterase inhibitor

A; Placebo

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 8 years old
• Diagnosed to have Down syndrome.
• Full IQ \> 40
• Patients and caregiver agreed and could participated in this trial
• Have to sign permit. If patient is less than 18 years old, inform consent should be singed by parents

You may not qualify if:

• Known to be allergy to Rivastigmine
• Currently uncontrolled heart, gastrointestinal, renal or central nervous system problems that could effect evaluation or compliance A. Heart rate less than 50/min B. Patients has uncontrolled severe disease such as gastric ulcer, uncontrolled hypothyroidism, vit B12 deficiency, severe renal or liver disease, diabetes, or asthma C. Uncontrolled psychiatric disease D. Diagnosed to have primary neurodegenerative disease such as Huntington's disease, uncontrolled seizure, delirium E. Hearing defects or vision effect that will affect neuropsychiatric evaluations F. Pregnancy
• Currently usage of special medications A. Toxic agents to major organs 4 weeks before using Rivastigmine B. Taking drugs for psychiatric problems 4 weeks before using Rivastigmine C. Taking Rivastigmine 6 weeks before entering the trial D. Taking other acetylcholinesterase inhibitors such as Donepezil (Aricept)、Galantamine (Razadyne, Razadyne ER)、Anticholinergic agents, such as diphenhydramine (Benadryl), oxybutynin (Ditropan), or N-Methyl-D-Aspartate (NMDA) receptor antagonist such as Memantine (Namenda)
• Not willing to cooperate with follow up programs
• Other conditions that doctors or investigators consider not suitable to enter this trial

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Medical Genetics, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Down Syndrome

Interventions

Rivastigmine; Cholinesterase Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs

Study Officials

• Wuh-Liang Hwu, MD. PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wuh-Liang Hwu

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

TW (1)