Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10

NCT00754013

Last updated date
Study Location
Road Runner Research
San Antonio, Texas, 78258, 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, Cognitive Dysfunction
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-10 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age range: Subjects 6 to 10 years of age at the screening visit; weight >= 15 kg.

- Sex distribution: both males and females.

- VABS-II/PCRF receptive sub-domain raw score of >= 25 and expressive sub-domain raw score of >= 61.

- Clinical diagnosis of Down syndrome (DS) - subjects may have free trisomy 21, Robertsonian translocations, or mosaic DS

- Naive to approved or unapproved cholinesterase inhibitors (Aricept, Exelon, Cognex, Reminyl/Razadyne, metrifonate, physostigmine) 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 patient in the study. The exception to this prior use is that subjects who participated in the Phase II study E2020-A001-219 (A2501059) are not eligible.

- Subjects residing in the community or in facilities that have consistent and reliable caregivers who can provide efficacy information about the subjects.

- The subjects must be expected to complete all procedures scheduled during the Screening and Baseline visits including all efficacy and safety parameters. Subjects who are verbal and able to be understood most of the time are preferred, but those who use other forms of communication, signs, symbol boards or devices to supplement his/her communication ability may be enrolled provided they meet the VABS-II/PCRF receptive and expressive score criteria mentioned above.

- Subjects 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.

- The 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 functioning in order to be able to complete the VABS-II/PCRF accurately. The same individual should complete the form at every visit if possible.

- Subjects 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.

- Subjects with 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. (Adequacy of control is based on the investigator's judgment, but should be guided primarily by a glycosylated hemoglobin [hemoglobin A1c] <8.0 at screening; other information, including records of home monitoring and the screening fasting glucose may support this judgment.)

- Subjects with thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 1 month prior to screening.

- Subjects with a history of seizure disorder are allowed provided that they are on stable treatment for at least 3 months and have not had a seizure within the past 6 months.

- Subjects should be independent in ambulation or ambulatory aided (i.e., walker or cane, to wheelchair); vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for achieving VABS-II/PCRF minimum receptive raw scores of >= 25 and expressive scores of >= 61 and for cooperating with secondary efficacy evaluations and study examinations.

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


- Age range: Subjects <6 or >10 years at the screening visit.


- Subjects with active or clinically significant conditions that will, in the
investigator's judgment, affect absorption, distribution or metabolism of the study
medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe
lactose intolerance); controlled celiac disease is allowed.


- Subjects with a known hypersensitivity to piperidine derivatives or cholinesterase
inhibitors.


- Subjects 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 or simply to enroll the subject in this
study. Also excluded are subjects who participated in the Phase II study
E2020-A001-219 (A2501059). In addition, subjects may not have taken any other
investigational medications (including memantine) within 3 months prior to screening.


- Subjects without a reliable parent or caregiver (caregiver responsibilities are
described in the Inclusion Criteria above), or with parents or caregivers who are
unwilling or unable to complete any of the outcome measures and fulfill the
requirements of this study.


- Subjects with clinically significant obstructive pulmonary disease or asthma,
untreated or not controlled by treatment within 3 months prior to screening.


- Subjects with recent (<= 1 year) or ongoing hematologic/oncologic disorders (mild
anemia allowed).


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


- Subjects with a current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric
diagnosis other than DS (as per DSM-IV). Diagnoses that are secondary, such as
attention deficit hyperactivity disorder, are allowed.


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

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Down Syndrome, Cognitive DysfunctionEvaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
NCT00754013
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  2. Herndon, Virginia
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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
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, Aged 6 To 10
Brief Summary The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged 6 to 10 years.
Detailed Description This is a multinational study with sites in the US, India, Singapore, South Korea, Mexico and Chile. There will be 210 subjects (male or female) enrolled that are residing in community or facilities with a reliable caregiver that have been clinically diagnosed with Down syndrome. The assessments performed during this study will be used to evaluate skills. The study duration will be 10 weeks of double blind treatment with a total of 6 visits; 4 in office visit and 2 phone visits.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Down Syndrome
  • Cognitive Dysfunction
Intervention  ICMJE
  • Drug: Aricept (Donepezil hydrochloride)

    All subjects will start with a dose of 1.25 mg/day (1.25 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil.

    All doses will be administered orally.

    Other Name: Donepezil hydrochloride
  • Drug: Placebo

    All subjects will start with a dose of 1.25 mg/day (1.25 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) placebo.

    All doses will be administered orally.

Study Arms  ICMJE
  • Active Comparator: Donepezil
    Intervention: Drug: Aricept (Donepezil hydrochloride)
  • Placebo Comparator: Placebo
    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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 11, 2013)
9
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2008)
140
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age range: Subjects 6 to 10 years of age at the screening visit; weight >= 15 kg.
  • Sex distribution: both males and females.
  • VABS-II/PCRF receptive sub-domain raw score of >= 25 and expressive sub-domain raw score of >= 61.
  • Clinical diagnosis of Down syndrome (DS) - subjects may have free trisomy 21, Robertsonian translocations, or mosaic DS
  • Naive to approved or unapproved cholinesterase inhibitors (Aricept, Exelon, Cognex, Reminyl/Razadyne, metrifonate, physostigmine) 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 patient in the study. The exception to this prior use is that subjects who participated in the Phase II study E2020-A001-219 (A2501059) are not eligible.
  • Subjects residing in the community or in facilities that have consistent and reliable caregivers who can provide efficacy information about the subjects.
  • The subjects must be expected to complete all procedures scheduled during the Screening and Baseline visits including all efficacy and safety parameters. Subjects who are verbal and able to be understood most of the time are preferred, but those who use other forms of communication, signs, symbol boards or devices to supplement his/her communication ability may be enrolled provided they meet the VABS-II/PCRF receptive and expressive score criteria mentioned above.
  • Subjects 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.
  • The 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 functioning in order to be able to complete the VABS-II/PCRF accurately. The same individual should complete the form at every visit if possible.
  • Subjects 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.
  • Subjects with 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. (Adequacy of control is based on the investigator's judgment, but should be guided primarily by a glycosylated hemoglobin [hemoglobin A1c] <8.0 at screening; other information, including records of home monitoring and the screening fasting glucose may support this judgment.)
  • Subjects with thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 1 month prior to screening.
  • Subjects with a history of seizure disorder are allowed provided that they are on stable treatment for at least 3 months and have not had a seizure within the past 6 months.
  • Subjects should be independent in ambulation or ambulatory aided (i.e., walker or cane, to wheelchair); vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for achieving VABS-II/PCRF minimum receptive raw scores of >= 25 and expressive scores of >= 61 and for cooperating with secondary efficacy evaluations and study examinations.

Exclusion Criteria:

  • Age range: Subjects <6 or >10 years at the screening visit.
  • Subjects with active or clinically significant conditions that will, in the investigator's judgment, affect absorption, distribution or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe lactose intolerance); controlled celiac disease is allowed.
  • Subjects with a known hypersensitivity to piperidine derivatives or cholinesterase inhibitors.
  • Subjects 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 or simply to enroll the subject in this study. Also excluded are subjects who participated in the Phase II study E2020-A001-219 (A2501059). In addition, subjects may not have taken any other investigational medications (including memantine) within 3 months prior to screening.
  • Subjects without a reliable parent or caregiver (caregiver responsibilities are described in the Inclusion Criteria above), or with parents or caregivers who are unwilling or unable to complete any of the outcome measures and fulfill the requirements of this study.
  • Subjects with clinically significant obstructive pulmonary disease or asthma, untreated or not controlled by treatment within 3 months prior to screening.
  • Subjects with recent (<= 1 year) or ongoing hematologic/oncologic disorders (mild anemia allowed).
  • Evidence of active, clinically significant, and unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
  • Subjects with a current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than DS (as per DSM-IV). Diagnoses that are secondary, such as attention deficit hyperactivity disorder, are allowed.
  • Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 10 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 NCT00754013
Other Study ID Numbers  ICMJE E2020-A001-336
A2501061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Thomas McRae, MDPfizer
PRS Account Eisai Inc.
Verification Date February 2017

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