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NCT02304302 · ClinicalTrials.gov registry record · Phase 2
Down Syndrome Memantine Follow-up Study
A Phase 2 study of Down Syndrome and Intellectual Disability, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 2
- Study locations
NCT02304302: Completed Phase 2 study of Down Syndrome and Intellectual Disability, sponsored by University Hospitals Cleveland Medical Center.
NCT02304302 is a Phase 2 study of Down Syndrome and Intellectual Disability that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 160 participants, below the 2,469-participant average among 54 other Down Syndrome trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02304302, a Phase 2 study of Down Syndrome and Intellectual Disability, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The primary efficacy measure is focused on episodic memory. The CVLT-II short form assesses supraspan word learning ability as an index of episodic verbal long-term memory. We hypothesize that treatment with memantine will produce significant improvements in this test. The main dependent variable selected, based on prior literature was the total number of target items correct summed across learning trials 1-4. The values for this measure have been recorded as change in score from baseline (T1) t
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Memantine
Study Locations (2)
Ohio
- University Hospitals Case Medical Center - Cleveland
São Paulo
- Sociedade Beneficente Israelita Brasileira Albert Einstein - São Paulo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2014-10 |
| Est. Completion | 2020-07-22 |
| Phase | Phase 2 |
What the finished NCT02304302 record still lists
NCT02304302 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 2,469-participant average among 54 other Down Syndrome trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Down Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02304302 reports a single indexed study location in Ohio, São Paulo.
Frequently Asked Questions
What is clinical trial NCT02304302 about?
NCT02304302 is a clinical study titled "Down Syndrome Memantine Follow-up Study". 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 abil...
What is the current status of trial NCT02304302?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2014-10. Estimated completion is 2020-07-22.
What conditions does trial NCT02304302 study?
This clinical trial studies the following conditions: Down Syndrome, Intellectual Disability.
What interventions are being tested in trial NCT02304302?
The interventions under investigation include: Placebo (DRUG), Memantine (DRUG).
Who is sponsoring clinical trial NCT02304302?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02304302 being conducted?
This trial has 2 study locations across Ohio, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Down Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02304302's enrollment target sits among peer trials
160 21st of 54 higher than 34 of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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