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NCT07531940 · ClinicalTrials.gov registry record · Phase 1
Escalating Doses of Memantine in Down Syndrome (MEDS-123)
A Phase 1 study, sponsored by University Hospitals Cleveland Medical Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT07531940: Clinical Trial Phase 1 study, sponsored by University Hospitals Cleveland Medical Center.
NCT07531940 is a Phase 1 study that has not yet begun recruiting, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07531940, a Phase 1 study, has not yet begun recruiting, sponsored by University Hospitals Cleveland Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Down syndrome (DS) is typically caused by an extra chromosome 21 in the cell nucleus (trisomy 21, or T21). T21 is both the most common cause of genetically defined intellectual disability and the earliest documented cause of Alzheimer's disease (AD)-type pathology. Currently, all presymptomatic individuals with DS are classified as having 'Stage 0' DS-associated AD (DSAD). DSAD pathology evolves inexorably, with virtually all individuals with DS developing AD pathology by age 40, and approximately 50% meeting clinical dementia diagnosis criteria at 55 years of age. This study will test the hypothesis that the FDA-approved AD drug memantine, at higher-than-standard doses, may be effective as a cognitive enhancer in adolescents and young adults with DS. The primary goal of this phase 1b clinical trial will be the assessment of the safety and tolerability of three memantine doses in persons with DS. In addition, we will assess the effect of this drug on cognitive test scores and plasma biomarkers of AD in the study participants. Finally, we will also investigate steady-state plasma levels of memantine and the time course of memantine plasma levels after a single dose in the study participants (pharmacokinetics, or PK). The data generated through this phase 1b study will provide the essential safety, PK, and preliminary efficacy signals required to advance a phase 2 trial evaluating high-dose memantine as a first-in-class therapeutic strategy in DS.
Primary Outcome
Incidence of adverse events (AEs) will be monitored by clinical history, physical examinations, electrocardiograms (ECGs), and clinical laboratory tests during and after exposure to the three doses of memantine (20, 40, and 60 mg/day; PO). Investigators will record any AE reported by the participants and caregivers and any clinically significant abnormalities in physical examination, ECGs, and laboratory tests. Memantine is expected to be well tolerated at higher than the typical dose used in th
Interventions
- DRUG Memantine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-05 |
| Phase | Phase 1 |
What is known before NCT07531940 opens enrollment
NCT07531940 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Memantine is the first listed.
NCT07531940 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07531940 about?
NCT07531940 is a clinical study titled "Escalating Doses of Memantine in Down Syndrome (MEDS-123)". Down syndrome (DS) is typically caused by an extra chromosome 21 in the cell nucleus (trisomy 21, or T21). T21 is both the most common cause of genetically defined intellectual disability and the earliest documented cause of Alzheimer's disease (AD)-type pathology. Currently, all presymptomatic indi...
What is the current status of trial NCT07531940?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2026-06. Estimated completion is 2028-05.
What interventions are being tested in trial NCT07531940?
The interventions under investigation include: Memantine (DRUG).
Who is sponsoring clinical trial NCT07531940?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07531940's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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