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Down Syndrome Memantine Follow-up Study

NCT02304302 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-06-27

Study results available
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Summary

The purpose of this research study is to learn if the medication Memantine Hydrochloride (the study medication) can help adolescents and young adults with Down syndrome. Dr. Alberto Costa and his research team want to see if a 16-week treatment with this medication can improve the participant's ability to learn and remember things. In this study, memantine hydrochloride will be used. Thus, the researchers want to learn whether the study drug can help improve memory in young adults with Down syndrome. To test the effect of the study medicine, half of the people in the study will receive the study medicine and half will receive a placebo (an inactive substance). Memantine is an approved medication to treat memory and thinking problems in persons with Alzheimer disease. However, little is known about the effect of this medication in persons with Down syndrome and it has not been approved for use in persons with Down syndrome.

Conditions

  • Down Syndrome
  • Intellectual Disability

Interventions

DRUG

Memantine

Encapsulated Namenda 10 mg bid (after four-week standard dose titration protocol)

DRUG

Placebo

Identically looking placebo capsules bid (after a four-week regimen designed to mimic standard dose titration protocol)

Sponsors & Collaborators

  • Alana USA Foundation

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Alberto C Costa, MD, PhD · University Hospitals Cleveland Medical Center

  • Stephen L Ruedrich, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
32 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-07-22
Completion
2020-07-22

Countries

  • United States
  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02304302 on ClinicalTrials.gov