Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome

NCT00570128

Last updated date
Study Location
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Down Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Ages 10 to 17 years old, weight more than or equal to 20kg

- Male and female

- VABS-II/PCRF standard composite score >55

- Diagnosis of DS (trisomy 21) documented by chromosomal analysis (karyotyping). If such documentation is not available at screening, karyotyping will be performed with the screening labs and must be documented prior to baseline visit.

- Naïve to approved or unapproved cholinesterase inhibitors is preferred however, prior use of these medications is allowed, provided that the medication was discontinued at least 3 months prior to screening and that it was not discontinued for lack of tolerability or efficacy or for the sole purpose of enrolling the subject in the study.

- Subjects residing in the community

- Must be expected to complete all procedures scheduled during the Screening and Baseline visits including all efficacy and safety parameters.

- Must speak English and be verbal and able to be understood most of the time and must not use other forms of communication, signs, symbol boards or devices to supplement his/her communication ability

- Must have a parent or other reliable caregiver who agrees to accompany the subject to all clinic visits, provide information about the subject as required by the protocol, and ensure compliance with the medication schedule

- a Parent or Caregiver must be a constant and reliable informant with sufficient contact with the subject to have detailed knowledge of the subject's adaptive behavior in order to be able to complete the VABS-II/PCRF accurately. The same individual should complete the form at every visit.

- Should be in good general health with no medical conditions that are considered both clinically significant and unstable

- Clinical laboratory values within normal limits or abnormalities considered not clinically significant by the investigator and sponsor

- Stable Type I (insulin-dependent) or Type II diabetes are eligible provided they are monitored regularly prior to and during the study to ensure adequate glucose control (fasting blood glucose < 140mg/dl and glycosylated hemoglobin [hemoglobin A1c] <8% at screening).

- Thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 3 months prior to screening.

- History of seizure disorder is allowed provided that subjects are on stable treatment for at least 3 months and have not had a seizure within the past 6 months.

- Independent in ambulation or ambulatory aided (i.e., walker or cane, wheelchair), vision and hearing (eyeglasses and/ or hearing aid permissible) sufficient for achieving VABS-II/PCRF composite standard scores >55 and for cooperating with examinations and the TOVER.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Ages <10 or >17 years


- Active or clinically significant conditions affecting absorption, distribution or
metabolism of the study medication (e.g., inflammatory bowel disease, gastric or
duodenal ulcers or severe lactose intolerance)


- Known hypersensitivity to piperidine derivatives or cholinesterase inhibitors


- Currently receiving cholinesterase inhibitors or who have received them in the 3
months prior to screening or with prior use >3 months prior to screening who stopped
for lack of efficacy or tolerability


- No reliable parent or caregiver, or subjects, or caregivers who are unwilling or
unable to complete any of the outcome measures and fulfill the requirements of this
study


- Clinically significant obstructive pulmonary disease or asthma untreated or not
controlled by treatment within 3 months prior to screening


- Recent (less than or equal to 2 years) hematologic/oncologic disorders (mild anemia
allowed)


- Evidence of active, clinically significant, and unstable gastrointestinal, renal,
hepatic, endocrine or cardiovascular system disease


- Current DSM-IV-TR diagnosis of Major Depressive Disorder (MDD) or any current primary
psychiatric diagnosis other than DS (as per DSM-IV)


- Any condition which would make the subject or the caregiver, in the opinion of the
investigator, unsuitable for the study


- Unsuitability which includes female subjects who have begun menstruation and are thus
of child-bearing potential, who may be sexually active and who are not practicing an
effective means of birth control.

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NCT00570128
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  4. Oakland, California
  5. Orange, California
  6. San Diego, California
  7. Lakewood, Colorado
  8. Fort Myers, Florida
  9. Miami, Florida
  10. Miami, Florida
  11. Miami, Florida
  12. St. Petersburg, Florida
  13. West Palm Beach, Florida
  14. Atlanta, Georgia
  15. Flint, Michigan
  16. Grand Rapids, Michigan
  17. Grand Rapids, Michigan
  18. Saint Paul, Minnesota
  19. Saint Louis, Missouri
  20. Lincoln, Nebraska
  21. Voorhees, New Jersey
  22. Durham, North Carolina
  23. Cleveland, Ohio
  24. Toledo, Ohio
  25. Tulsa, Oklahoma
  26. Charleston, South Carolina
  27. Nashville, Tennessee
  28. Houston, Texas
  29. San Antonio, Texas
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  31. Bellevue, Washington
ALL GENDERS
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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome
Official Title  ICMJE A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome
Brief Summary The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome. Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 10 to 17.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Down Syndrome
Intervention  ICMJE
  • Drug: Donepezil hydrochloride
    Oral liquid.
    Other Name: Aricept
  • Drug: Placebo
    Oral liquid.
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Donepezil hydrochloride
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 7, 2007)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 10 to 17 years old, weight more than or equal to 20kg
  • Male and female
  • VABS-II/PCRF standard composite score >55
  • Diagnosis of DS (trisomy 21) documented by chromosomal analysis (karyotyping). If such documentation is not available at screening, karyotyping will be performed with the screening labs and must be documented prior to baseline visit.
  • Naïve to approved or unapproved cholinesterase inhibitors is preferred however, prior use of these medications is allowed, provided that the medication was discontinued at least 3 months prior to screening and that it was not discontinued for lack of tolerability or efficacy or for the sole purpose of enrolling the subject in the study.
  • Subjects residing in the community
  • Must be expected to complete all procedures scheduled during the Screening and Baseline visits including all efficacy and safety parameters.
  • Must speak English and be verbal and able to be understood most of the time and must not use other forms of communication, signs, symbol boards or devices to supplement his/her communication ability
  • Must have a parent or other reliable caregiver who agrees to accompany the subject to all clinic visits, provide information about the subject as required by the protocol, and ensure compliance with the medication schedule
  • a Parent or Caregiver must be a constant and reliable informant with sufficient contact with the subject to have detailed knowledge of the subject's adaptive behavior in order to be able to complete the VABS-II/PCRF accurately. The same individual should complete the form at every visit.
  • Should be in good general health with no medical conditions that are considered both clinically significant and unstable
  • Clinical laboratory values within normal limits or abnormalities considered not clinically significant by the investigator and sponsor
  • Stable Type I (insulin-dependent) or Type II diabetes are eligible provided they are monitored regularly prior to and during the study to ensure adequate glucose control (fasting blood glucose < 140mg/dl and glycosylated hemoglobin [hemoglobin A1c] <8% at screening).
  • Thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 3 months prior to screening.
  • History of seizure disorder is allowed provided that subjects are on stable treatment for at least 3 months and have not had a seizure within the past 6 months.
  • Independent in ambulation or ambulatory aided (i.e., walker or cane, wheelchair), vision and hearing (eyeglasses and/ or hearing aid permissible) sufficient for achieving VABS-II/PCRF composite standard scores >55 and for cooperating with examinations and the TOVER.

Exclusion Criteria:

  • Ages <10 or >17 years
  • Active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe lactose intolerance)
  • Known hypersensitivity to piperidine derivatives or cholinesterase inhibitors
  • Currently receiving cholinesterase inhibitors or who have received them in the 3 months prior to screening or with prior use >3 months prior to screening who stopped for lack of efficacy or tolerability
  • No reliable parent or caregiver, or subjects, or caregivers who are unwilling or unable to complete any of the outcome measures and fulfill the requirements of this study
  • Clinically significant obstructive pulmonary disease or asthma untreated or not controlled by treatment within 3 months prior to screening
  • Recent (less than or equal to 2 years) hematologic/oncologic disorders (mild anemia allowed)
  • Evidence of active, clinically significant, and unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease
  • Current DSM-IV-TR diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than DS (as per DSM-IV)
  • Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study
  • Unsuitability which includes female subjects who have begun menstruation and are thus of child-bearing potential, who may be sexually active and who are not practicing an effective means of birth control.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00570128
Other Study ID Numbers  ICMJE E2020-A001-219
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Medical Services, Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Anita MurthyEisai Inc.
PRS Account Eisai Inc.
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP