Rivastigmine Study in Adolescents With Down Syndrome

NCT01084135 | Completed Phase 1 Results

• 1 other identifier: Pro00013682
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Down Syndrome

Keywords

Clinical trial; Down syndrome; adolescents; cognitive; rivastigmine

Outcome Measures

Primary Outcomes (1)

• Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)

  The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. In this study, the change between each subject's ABC at Baseline and the Final Visit was computed. A rise in standard scores from Baseline to the Final Visit indicates improvement.

  Baseline & Study termination (Week 20)

Secondary Outcomes (1)

• Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)

  Baseline and Final (Week 20) visit

Study Arms (2)

Rivastigmine- Liquid form

EXPERIMENTAL

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

Liquid placebo

PLACEBO COMPARATOR

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

Interventions

Rivastigmine DRUG

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.

Also known as: Rivastigmine-Excelon

Rivastigmine- Liquid form

Liquid Placebo OTHER

Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Liquid placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead
• Taishoff Family Foundation: collaborator
• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: collaborator

Study Sites (2)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Down Syndrome

Interventions

Rivastigmine

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

Results Point of Contact

• Title: Jane Ann Baker,MS, CGC
• Organization: Duke University Medical Center

janeann.mckillop@duke.edu

919-668-4576

Study Officials

• Priya Kishnani, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• George Capone, MD

  Kennedy Krieger Institute/Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: November 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 6, 2015
• Results First Posted: March 12, 2015

Record last verified: 2015-02

Locations

US (2)