Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
Interventions
- DRUG Memantine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07531940
The ClinicalTrials.gov registry entry for NCT07531940 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Memantine is the first listed.
NCT07531940 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.