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NCT01112683 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Memantine Hydrochloride in Enhancing the Cognitive Abilities of Young Adults With Down Syndrome
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
NCT01112683: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT01112683 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 42 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01112683, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this 16-week research study is to determine whether a drug called memantine hydrochloride (memantine) has the potential to help improve memory and other cognitive abilities of young adults with Down syndrome (DS). Memantine (Namenda®) is a drug approved by the Food and Drug Administration (FDA) for patients with moderate to severe Alzheimer-type dementia. About 40 persons of both genders with Down syndrome aged 18-32 years will take part in this study. This is a randomized and double blind study. This means that subjects will have a 50/50 chance of being assigned to receive either the memantine pills or placebo (inactive pills). Neither the study participants nor the research personnel will know who is receiving active medication or placebo. Based on memantine's mode of action, current knowledge on brain pathology in persons with Down syndrome, and some preclinical data on mouse models of Down syndrome, we hypothesize that memantine may improve test scores of young adults with Down Syndrome on memory tests targeted at the function of the brain structure called the hippocampus. This research project has three specific aims: 1) investigate whether memantine has the potential to improve test scores on hippocampus-dependent measures in young adults with Down syndrome; 2) investigate whether memantine has the potential to improve test scores by these subjects on other cognitive measures; 3) investigate whether memantine is well tolerated by these subjects.
Primary Outcome
The hippocampus-dependent measures assessed in the present study are 1. Pattern recognition memory\* - Measures visual memory for non-namable designs; scale range in dataset 4-24; higher score indicates better performance 2. Paired associates task\* - Measures ability to learn visual associations between a picture and its location, and retention of this information over time; scale range in dataset 0-17; higher score indicates better performance 3. California Verbal Learning Test (CVLT) - Child
Interventions
- DRUG Placebo
- DRUG Memantine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
What the finished NCT01112683 record still lists
NCT01112683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01112683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01112683 about?
NCT01112683 is a clinical study titled "Efficacy and Safety of Memantine Hydrochloride in Enhancing the Cognitive Abilities of Young Adults With Down Syndrome". The purpose of this 16-week research study is to determine whether a drug called memantine hydrochloride (memantine) has the potential to help improve memory and other cognitive abilities of young adults with Down syndrome (DS). Memantine (Namenda®) is a drug approved by the Food and Drug Administra...
What is the current status of trial NCT01112683?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2008-07. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01112683?
The interventions under investigation include: Placebo (DRUG), Memantine (DRUG).
Who is sponsoring clinical trial NCT01112683?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01112683's enrollment target sits among peer trials
42 1380th of 2000 higher than 611 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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