Escalating Doses of Memantine in Down Syndrome (MEDS-123)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT07531940
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Down Syndrome
  • Intellectual Disability

Eligibility Criteria

Sex
ALL
Age
15 Years - 32 Years
Healthy Volunteers
Not accepted

Interventions

  • Memantine — DRUG
    Escalating doses of Memantine (20 mg/day; 40 mg/day; 60 mg/day)

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Memantine
    Three escalating oral doses of Memantine will be administered: 1) Memantine 10 mg, one tablet bid orally for nine weeks (including four-week standard dose titration protocol); 2) Memantine 10 mg, two tablets bid orally for nine weeks (including four-week dose titration); 3) Memantine 10 mg, three tablets bid orally for nine weeks (including four-week dose titration). This will be followed by a nine-week washout period and a single 20 mg oral dose of memantine to generate pharmacokinetic (PK) data.

Primary Outcome Measure

Safety and Tolerability (as measured by incidence of adverse events) [ Time Frame: 36 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Case Medical CenterClevelandOhio44106
Melissa R Stasko, JD
[email protected]
216-983-2153
Alberto C Costa, MD, PhD
[email protected]
216-983-5613
Alberto C Costa, MD, PhD (PRINCIPAL_INVESTIGATOR)
Stephen L Ruedrich, MD (SUB_INVESTIGATOR)
Katherine Koenig, PhD (SUB_INVESTIGATOR)
Richard Boada, PhD (SUB_INVESTIGATOR)

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By research site
University Hospitals Case Medical Center· Cleveland, OH

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