Memantine for Down Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether higher doses of memantine, a drug approved for Alzheimer's disease, can enhance cognitive function in adolescents and young adults with Down syndrome. Researchers aim to determine if this treatment can improve memory and thinking skills while also assessing its safety and metabolism in the body. The trial suits individuals with confirmed Down syndrome who are in good health, can swallow pills, and have a caregiver to assist with study requirements. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Do I have to stop taking my current medications for the trial?
The trial requires participants to stop taking any experimental drugs for Down syndrome before joining. If you are currently on psychotropic drugs (medications affecting mood, perception, or behavior), you cannot participate in the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Earlier research found memantine to be well tolerated by teenagers and young adults with Down syndrome. At a dose of 20 mg per day, no major safety issues emerged. However, this dose did not improve thinking or memory in these individuals. The FDA has already approved memantine for treating Alzheimer's disease, indicating its general safety.
This trial tests higher doses of memantine. As this is an early stage of research, the primary focus is on collecting safety information. Initial signs suggest that memantine might be well tolerated even at higher doses, but this trial aims to provide more detailed information about its safety in people with Down syndrome.12345Why do researchers think this study treatment might be promising?
Unlike standard treatments for Down syndrome, which primarily focus on managing symptoms through supportive therapies and medications for specific health issues, memantine is unique because it targets cognitive improvement directly. Memantine acts on the brain's NMDA receptors, which play a role in memory and learning. Researchers are excited about memantine because it could potentially enhance cognitive function, offering a new avenue for improving quality of life for individuals with Down syndrome. This approach distinguishes it from existing options that do not address cognitive deficits as directly.
What evidence suggests that memantine might be an effective treatment for Down syndrome?
Research has shown that memantine can improve thinking skills and slow the decline of Alzheimer's disease. However, studies on individuals with Down syndrome have produced mixed results. Some research found no significant improvement in thinking skills for people with Down syndrome, even when higher doses were used and tolerated well. Specifically, adolescents and young adults with Down syndrome showed no improvement in cognitive abilities. While memantine is safe, its effectiveness in enhancing thinking skills for people with Down syndrome remains uncertain. This trial will investigate the effects of escalating doses of memantine on cognitive function in individuals with Down syndrome.13456
Who Is on the Research Team?
Alberto C Costa, MD, PhD
Principal Investigator
University Hospitals Cleveland Medical Center
Stephen L Ruedrich, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Are You a Good Fit for This Trial?
This trial is for adolescents and young adults with Down syndrome (Trisomy 21 or complete unbalanced translocation), in generally good health, able to swallow pills, have a reliable caregiver, and can understand English. Participants must not be pregnant and must not have certain genetic variations of Down syndrome.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive escalating doses of memantine (20 mg/day, 40 mg/day, and 60 mg/day) for 9 weeks at each dosing stage
Washout
Participants undergo a washout period to evaluate the reversibility of any observed drug effect
Pharmacokinetics
A single 20 mg oral dose of memantine is administered to evaluate absorption, distribution, and excretion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Memantine
Trial Overview
The study tests different higher-than-standard doses of memantine (an Alzheimer's drug) to see if it is safe and well-tolerated in people with Down syndrome. It also looks at how the drug affects thinking skills and measures its levels in the blood.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Two escalating oral doses of Memantine will be administered (with a third dose of 60 mg/day that may be approved by the FDA, pending safety data to be collected at the 40 mg/day dose level in the first 10 study participants): 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); and potentially Memantine 10 mg, three tablets bid orally for nine weeks (pending FDA approval). This will be followed by a nine-week washout period and a single 20 mg oral dose of memantine to generate pharmacokinetic (PK) data.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical Center
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Citations
Memantine for dementia in people with Down syndrome - PMC
Memantine is thought to improve cognitive function and slow the decline of AD over time.The effects of memantine on AD are reported to be beneficial.
The role of Memantine in slowing cognitive decline in ...
Our study finds no statistically significant therapeutic effect of Memantine in comparison to placebo in Down syndrome patients.
Escalating Doses of Memantine in Down Syndrome (MEDS ...
Safety, efficacy, and tolerability of memantine for cognitive and adaptive outcome measures in adolescents and young adults with Down syndrome ...
a randomised, double-blind, placebo-controlled phase 2 trial
Memantine was well tolerated, but cognition-enhancing effects were not recorded with a 20 mg/day dose in adolescents and young adults with Down syndrome.
5.
neurologyadvisor.com
neurologyadvisor.com/news/memantine-therapy-down-syndrome-little-benefit-young-adults/Memantine Therapy for Down Syndrome Shows Little ...
A dose of 20 mg/day of memantine was safe but did not have cognitive-enhancing effects in adolescents and young adults with Down syndrome.
Safety, efficacy, and tolerability of memantine for cognitive ...
Memantine was well tolerated, but cognition-enhancing effects were not recorded with a 20 mg/day dose in adolescents and young adults with Down syndrome.
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