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MEDS-123: Escalating Doses of Memantine in Down Syndrome

This study, called MEDS-123, is looking at whether higher doses of memantine, a drug approved for Alzheimer's disease, can help improve thinking skills in adolescents and young adults with Down syndrome. Researchers believe that a problem with certain brain receptors (NMDA receptors) might play a role in Down syndrome. Previous studies with standard doses of memantine didn't show much improvement, possibly because the drug levels in the body were too low. This study will test escalating doses of memantine (20 mg/day, 40 mg/day, and 60 mg/day) to see if higher levels are more effective. You may be able to join if you are 15 to 32 years old, have Down syndrome (specifically Trisomy 21 or a complete unbalanced translocation of Chromosome 21), and, if you are a female of child-bearing potential, you are not pregnant and are using reliable birth control. The main goal is to check the safety and how well people tolerate these higher doses. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 25 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured at 36 weeks.

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NCT07531940

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

Not Yet Recruiting
PHASE1Ages 15–32InterventionalTreatment
University Hospitals Cleveland Medical Center
~25 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Memantine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability (as measured by incidence of adverse events)
Measured over 36 weeks

Conditions

Down Syndrome
Intellectual Disability

Explore related trials

Down Syndrome

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Alberto C Costa, MD, PhD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center
  • Stephen L Ruedrich, MD · STUDY_DIRECTOR · University Hospitals Cleveland Medical Center

Who to contact

Melissa R Stasko, JD
[email protected]
216-844-7281
Email the study team

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Eligibility criteria

Inclusion

Cytogenetically documented Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21. Mosaic Trisomy 21 and partial translocations will be excluded from the study
No pregnancy by serum testing at screening. Females of child-bearing potential, sexually active must be practicing a reliable method of birth control. Urine pregnancy tests will be done at the 2 follow-up medical visits
Laboratory findings within normal limits or judged clinically insignificant at baseline
Vital signs within normal limits for age. Stable, medically treated hypotension will be allowed
ECG must demonstrate predominately normal sinus rhythm. Minor abnormalities documented as clinically insignificant will be allowed
Participants and their authorized representatives will provide written informed consent
Participants who have received any experimental drug for Down syndrome must undergo a washout
All participants must: Be in general good health as judged by the investigators; Be able to swallow oral medication; Have a reliable caregiver or family member who agrees to accompany participant to all visits, provide information about the participant as required by the protocol, and ensure compliance with the medication schedule; Be sufficiently proficient in English to reliably complete the study assessments
Age and gender matching participants without Down syndrome, must be: Males or females without Down syndrome aged-matching (within 3 years) participants with Down syndrome whom they are expected to serve as controls

Exclusion

Participant weighing less than 40 kg
Current psychiatric or neurologic diagnosis other than Down syndrome (e.g., major depressive disorder, schizophrenia, bipolar disorder, autism, Alzheimer disease)
Current treatment with psychotropic drugs
Drug or alcohol abuse or dependence
Significant suicide risk or who would require treatment with electro-convulsive therapy or with psychotropic drugs during the study or who have received treatment with a depot neuroleptic drug within 6 months of entering the study.
Current or expected (within the next 6 months) hospitalization or residence in a skilled nursing facility (may reside in group homes or other residential settings with no skilled nursing)
Active or clinically significant conditions affecting absorption, distribution, or metabolism of study drug (e.g. inflammatory bowel disease or celiac disease)
Significant allergies to or other significant intolerance of memantine therapy, its ingredients, or with contraindications to memantine therapy as stated in the prescribing information
Participants who are expected to require general anesthetics during the course of the study
Presence or recent history of seizure disorder (\< 3 years).
Clinically significant and/or clinically unstable systemic disease. (Those with controlled hypothyroidism must be on a stable dose of medication for at least 3 months prior to screening and have normal serum T-4 and TSH at screening; and those with controlled diabetes mellitus must have an HbA1c of \< 8.0% and a random serum glucose value of \< 170 mg/dl)
Severe infections or a major surgical operation within 3 months prior to screening
History of persistent cognitive deficits immediately following head trauma.
Donation of blood or blood products less that 30 days prior to screening, while participating in the study, or four weeks after completion of the study
Inability to comply with the protocol or perform the outcomes measures due to significant hearing or visual impairment or other issues judged relevant by the investigators

What this trial measures

  • Safety and Tolerability (as measured by incidence of adverse events)36 weeks

    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 the treatment of Alzheimer's disease (20 mg/day) by at least 70% of the study participants (more precisely, \< 8 participants will drop out of the study due to AEs related to the study medication). Participation discontinuation can be initiated by either the PI/co-investigators or participant/caregiver. If a high number of AEs happen at the 60 mg/day dose of the study medication, the use of this particular dose may be suspended, with only the 40 mg/day dose used thereafter.