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

NCT ID
NCT07531940
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
University Hospitals Cleveland Medical Center
Conditions
Alzheimer Dementia (AD), Down Syndrome, Intellectual Disability

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: Phase 1B Trial on Escalating Doses of Memantine in Down Syndrome

Enrollment: 25 participants (Estimated).

What is being studied

  • Intervention: Adamantane
  • Intervention: Amantadine
  • Intervention: Bridged-Ring Compounds
  • Intervention: Hydrocarbons
  • Intervention: Hydrocarbons, Cyclic
  • Drug: Memantine
  • Intervention: Memantine
  • Intervention: Organic Chemicals

Who may be eligible

Ages
18 Years to 32 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Cytogenetically documented Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21. Mosaic Trisomy 21 and partial translocations will be excluded from the study. * Vital signs within normal limits for age. * 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 DS must undergo a washout for a minimum of 5 half-lives of any experimental medications. * 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 Exclusion Criteria: * Participant weighing less than 40 kg * Current psychiatric or neurologic diagnosis other than Down syndrome (This includes, but is not limited to, major depressive disorder, schizophrenia, schizoaffective disorder, any other psychotic disorder, bipolar disorder, seizure disorder (no seizures for more than 3 years), autism, Down syndrome regression disorder, Alzheimer disease, Parkinson's disease, cerebrovascular disease, other dementias, brain tumor, or other known structural brain abnormalities.) * Current treatment with psychotropic drugs. * Drug or alcohol abuse or dependence within past 5 years. * 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. * Use of NMDA receptor antagonists, such as amantadine (Symmetrel), ketamine, or dextromethorphan during the 30 days prior to screening. * 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. * Unexplained alkaline urine conditions. * Participants with severe renal impairment (i.e., estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73m2) will be excluded from the proposed clinical trial. The eGFR will be calculated using the eGFR Calculator from the National Kidney Foundation (https://www.kidney.org/professionals/gfr\_calculator) using serum creatinine, age, sex, adjusted for body surface area (for medication-related decision making, using Dubois Method). * Participants with severe hepatic impairment (Child-Pugh Category C) will also be excluded from the proposed clinical trial. Child-Pugh Category will be calculated using the MSD Professional Version online calculator (https://www.msdmanuals.com/professional/multimedia/clinical-calculator/child-pugh-classification-for-severity-of-liver-disease). * History of persistent cognitive deficits immediately following head trauma. (Note: remote history of head trauma without cognitive sequelae is not an exclusion.) * Cardiac QTc interval ≥ 480 ms. * History or presence of encephalitis. * 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 (\>40 dB hearing loss) or visual impairment (best corrected visual acuity of less than 20/60) or other clinically relevant issues, such as behavioral issues that may prevent full participation in the study.

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Ohio, United States: 1

Sample of listed locations

  • University Hospitals Case Medical Center — Cleveland, Ohio, 44106, United States — Site recruitment status not specified in the registry data

Study details

Start date
October 1, 2026
Primary completion date
May 1, 2028
Completion date
May 1, 2028
First posted
April 15, 2026
Collaborators
National Institute on Aging (NIA)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07531940
Registry last updated
September 21, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07531940 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Alzheimers Disease studies | Clinical trial FAQ