Rivastigmine Study in Adolescents With Down Syndrome (DS-Riv)

This study has been completed.
Sponsor:
Collaborators:
Taishoff Family Foundation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01084135
First received: March 8, 2010
Last updated: March 17, 2015
Last verified: February 2015
Results First Received: February 27, 2015  
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
Condition: Down Syndrome
Interventions: Drug: Rivastigmine
Other: Liquid Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
8 participant started and completed the 12 week period. The protocol was amended and 23 subject enrolled into the 20 week amended period (22 completed).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
42 subjects signed consent, 10 were screen failures, 1 withdrew consent prior to being assigned to an arm, 1 was withdrawn by PI after being assigned an arm for noncompliance, 30 completed study.

Reporting Groups
  Description
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.
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.

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.


Participant Flow for 2 periods

Period 1:   12 Week
    Rivastigmine- Liquid Form     Liquid Placebo  
STARTED     4     4  
COMPLETED     4     4  
NOT COMPLETED     0     0  

Period 2:   20 Week
    Rivastigmine- Liquid Form     Liquid Placebo  
STARTED     12     11  
COMPLETED     12     10  
NOT COMPLETED     0     1  
Physician Decision                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
20 Week 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.
20 Week 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.

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.

12 Week 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 four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
12 Week 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.

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.

Total Total of all reporting groups

Baseline Measures
    20 Week Rivastigmine- Liquid Form     20 Week Liquid Placebo     12 Week Rivastigmine- Liquid Form     12 Week Liquid Placebo     Total  
Number of Participants  
[units: participants]
  12     11     4     4     31  
Age  
[units: participants]
         
<=18 years     12     11     4     4     31  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     0     0     0     0     0  
Gender  
[units: participants]
         
Female     8     6     2     2     18  
Male     4     5     2     2     13  
Region of Enrollment  
[units: participants]
         
United States     12     11     4     4     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)   [ Time Frame: Baseline & Study termination (Week 20) ]

2.  Secondary:   Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)   [ Time Frame: Baseline and Final (Week 20) visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jane Ann Baker,MS, CGC
Organization: Duke University Medical Center
phone: 919-668-4576
e-mail: janeann.mckillop@duke.edu


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
Results First Received: February 27, 2015
Last Updated: March 17, 2015
Health Authority: United States: Institutional Review Board