Could a higher dose of an Alzheimer's drug boost thinking skills in down syndrome?
NCT ID NCT07531940
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 3 times
Summary
This early-stage trial will test whether higher-than-standard doses of memantine, a drug already approved for Alzheimer's, are safe and tolerable in 25 adolescents and young adults with Down syndrome. The study also looks for early signs that the drug might improve memory and thinking. It is a first step toward a larger trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 32 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
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Other studies related to the condition(s) this trial covers.
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