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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00570128

Public ClinicalTrials.gov record NCT00570128. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:21 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 (DS). Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 10 to 17.

Study identification

NCT ID
NCT00570128
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Eisai Inc.
Industry
Enrollment
129 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
10 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 16, 2007 (Actual)
Primary completion
Sep 5, 2008 (Actual)
Completion
Sep 5, 2008 (Actual)
Last update posted
Apr 19, 2021

2007 – 2008

United States locations

U.S. sites
31
U.S. states
19
U.S. cities
28
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016 —
Clinical Study Centers, L.L.C. Little Rock Arkansas 72205 —
Neufeld Medical Group, Inc. Los Angeles California 90048 —
Children's Hospital and Research Center at Oakland Oakland California 94609 —
University of California, Irvine Medical Center, Department of Pediatrics Orange California 92868 —
UCSD Pediatric Pharmacology Research Unit San Diego California 92123 —
Rocky Mountain Pediatrics Lakewood Colorado 80214 —
Neuropsychiatric Research Center of South West Florida Fort Myers Florida 33912 —
Miami Children's Hospital, Clinical Research Center Miami Florida 33155-3009 —
Community Research Foundation Miami Florida 33155 —
Miami Children's Hospital, Brain Institute Miami Florida 33155 —
Meridien Research St. Petersburg Florida 33709 —
Lazlo J. Mate, MD West Palm Beach Florida 33407 —
Child Neurology Associates, PC Atlanta Georgia 30342 —
Medical Genetics and Neuro Development Center Zionsville Indiana 46077 —
Hurley Medical Center Flint Michigan 48503 —
Saint Mayr's Health Care Grand Rapids Michigan 49503 —
Regions Hospital Saint Paul Minnesota 55101-2529 —
Washington University School of Medicine, Division of Genetics and Genomic Medicine St Louis Missouri 63110 —
Midwest Children's Health Research Institute, LLC Lincoln Nebraska 68504 —
Clinical Research Center of New Jersey Voorhees Township New Jersey 08043 —
Duke University Medical Center Durham North Carolina 27710 —
Metrohealth Medical Center, Division of Psychiatry Cleveland Ohio 44109 —
Valko and Associates Toledo Ohio 43606 —
Tulsa Clinical Research LLC Tulsa Oklahoma 74104-5428 —
Medical University of South Carolina, Division of Genetics and Developmental and Behavioral Pediatrics Charleston South Carolina 29425 —
Vanderbilt Children's Hospital Nashville Tennessee 37232-9225 —
Down Syndrome Clinic of Houston Houston Texas 77030 —
Alamo City Clinical Research, LLC San Antonio Texas 78258 —
Road Runner Research San Antonio Texas 78258 —
Northwest Clinical Research Center Bellevue Washington 98004 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00570128, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 19, 2021 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00570128 live on ClinicalTrials.gov.

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