Efficacy of Rivastigmine in Patients With Down Syndrome - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00748007

Purpose

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

Condition	Intervention
Down Syndrome	Drug: Rivastigmine

Genetics Home Reference related topics: Down syndrome

MedlinePlus related topics: Down Syndrome

Drug Information available for: Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Rivastigmine in Patients With Down Syndrome

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Scores of Vineland Adaptive Behavior Scales (VABS), Scores of WISC digit span, Scores of Leiter-R Forward memory , Scores of PPVT, [ Time Frame: at 24, and 54 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 24 and 54 wks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Rivastigmine Exelon (1.5mg/cap) 1.5 mg bid
B: Placebo Comparator	Drug: Rivastigmine Exelon (1.5mg/cap) 1.5 mg bid

Detailed Description:

Down syndrome (DS) is the most common cause of mental retardation due to chromosome anomaly. Besides defects in cognition, DS patients after 30 yeas old will have early dementia. Etiology of early dementia is known to be related with APP gene dosage triplication that is similar to the neuropathological change in Alzheimer disease (AD). It has been known that the cognitive degeneration in AD is related with decrement of cholinergic neurons in the brain. And the clinical improvement or delay in degeneration of cognitive function after utilization of cholinesterase inhibitor had been observed in mild to moderate AD patients. In DS brain, it has been also noted to be lower acetylcholine, supporting the relationship of pathology between DS and AD. Since 1999, Kishnani et al started to treat adult DS patients with cholinesterase inhibitor (Donepezil). Data showed the improvement of cognition and life quality in DS patients with dementia. Recently, data showed the low cholinergic neuron in DS brain might be a cause of cognitive dysfunction in DS. Therefore, early treatment of cholinesterase inhibitor in DS patients had been proposed to alleviate cognitive dysfunction. Since 2004, Kishnani et al started to treat DS children with Donepezil and Rivastigmine. Some patients showed improvement of language ability, memory, and attention. We are going to conduct a randomized, double-blind, placebo-controlled, crossover design, 12-month trial. Subjects who are enrolled in this study will be randomized into two groups. Each group will receive Rivastigmine and placebo in different order for 6 months. Neuropsychological assessment including Vineland Adaptive Behavior Scales and NEPSY will be evaluated before and after medication. Through this, we wish to understand the efficacy of this drug in the role of improving cognitive functioning in our patients.

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748007

Contacts

Contact: Wuh-Liang Hwu, MD. PhD

+886-2-23123456 ext 67541

hwuwlntu@ntu.edu.tw

Locations

Taiwan
Department of Medical Genetics, National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100
Contact: Lee +886-2-23123456 ext 67541
Principal Investigator: Wuh-Liang Hwu, MD. PhD

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Wuh-Liang Hwu, MD. PhD

National Taiwan University Hospital

More Information

Responsible Party:	National Taiwan University Hospital ( Tsai-Yi Wu/National Center of Exellence for Clinical Trial and Research )
Study ID Numbers:	200709028M
Study First Received:	September 5, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00748007
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Down syndrome, cholinesterase inhibitor, Rivastigmine

Study placed in the following topic categories:

Chromosomal abnormalities
Mental Retardation
Rivastigmine
Genetic Diseases, Inborn
Chromosome Disorders

Abnormalities, Multiple
Neurologic Manifestations
Down Syndrome
Congenital Abnormalities
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents

Protective Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Pathologic Processes
Therapeutic Uses
Syndrome
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009