What side effects are associated with this type of intervention?

Memantine, an NMDA receptor antagonist used in Alzheimer's Disease treatment, is generally well-tolerated but can cause side effects such as dizziness, headache, confusion, and constipation. Cholinesterase inhibitors, another common class of drugs for Alzheimer's, including donepezil, rivastigmine, and galantamine, can cause gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, fatigue, and insomnia. These side effects are important considerations when managing Alzheimer's Disease treatment.

What other types of research exist?

Promising novel alternatives to Memantine Hydrochloride for Alzheimer's Disease treatment in 2024 include: 1) Lecanemab, an anti-amyloid beta monoclonal antibody, which has shown efficacy in reducing amyloid plaques and slowing cognitive decline. 2) Donanemab, another anti-amyloid beta antibody, which targets a different epitope on amyloid plaques and has demonstrated promising results in clinical trials. 3) Aducanumab, an anti-amyloid beta antibody, which has been approved for early-stage Alzheimer's and aims to reduce amyloid plaque buildup in the brain.

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NMDA receptor antagonist

Memantine for Preventing Alzheimer's Disease

Q: What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Disease, including Memantine, an NMDA receptor antagonist that helps regulate glutamate activity to improve cognitive function. Other approved treatments include cholinesterase inhibitors such as Donepezil, Rivastigmine, and Galantamine, which work by increasing cholinergic transmission to provide symptomatic relief in patients with Alzheimer's Disease. These drugs offer modest benefits in cognition and global functioning but do not alter the underlying disease trajectory.

Phase 2

Recruiting

Led By Carol Manning, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a creatinine clearance (CrCl), estimated using the Cockcroft-Gault formula, greater or equal to 30 mL/minute

Previously known or documented heterozygote or homozygote ApoE ε4 allele

Must not have

Neurodegenerative disorder known to cause neurocognitive decline

Major surgery (e.g., requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the subject is expected to participate in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 months

Summary

This trial is testing memantine hydrochloride to see if it can prevent Alzheimer's Disease in people aged 50-65 who are at higher risk due to genetics and family history. The medication aims to protect brain cells from damage. Memantine hydrochloride is an FDA-approved drug used to treat Alzheimer's disease by reducing neurodegeneration in the hippocampus and cerebral cortex.

Who is the study for?

This trial is for people aged 50-65 with a family history of dementia and the ApoE ε4 allele, which increases Alzheimer's risk. Participants must be generally healthy or stable on medication, have good vision and hearing for tests, a MOCA score of 27+, and adequate kidney function. They can't join if they have MRI/PET scan issues, recent major surgery, are in another drug study, need certain medications that affect cognition or urine pH, or have significant health problems.

What is being tested?

The study is testing whether taking Memantine Hydrochloride Tablets can prevent Alzheimer's Disease in individuals at risk due to genetic factors. It compares the effects of memantine against a placebo (a pill without active medicine) to see if it helps maintain cognitive functions.

What are the potential side effects?

Memantine may cause side effects like dizziness, headache, constipation, confusion or sleepiness. However not everyone will experience these side effects and some might experience none at all.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys work well enough (CrCl ≥ 30 mL/min).

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I carry one or two copies of the ApoE ε4 gene.

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My cognitive function is good, with a MOCA score of 27 or above.

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I have a family member with dementia.

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I am between 50 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a brain disorder that affects my memory or thinking.

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I haven't had major surgery in the last 8 weeks and don't plan any during the study.

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I do not have active major organ or system diseases.

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I am currently receiving treatment for cancer.

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I take medication that changes the acidity of my urine.

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I have severe kidney or liver problems.

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I need medication for my condition, such as an AChE inhibitor or specific others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess the feasibility of the use of memantine hydrochloride for prevention of Alzheimer's Disease as measured by the percentage of patients who are lost to follow-up

Secondary study objectives

Intraclass correlation coefficient (ICC) for longitudinal follow-up

Mean change in RBANS scores from baseline to end of protocol, overall and in each arm.

Summary of demographic characteristics of subjects overall, and in each arm.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Memantine hydrochlorideExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors and NMDA receptor antagonists. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, increase acetylcholine levels by inhibiting the enzyme that breaks it down, thereby improving communication between nerve cells and providing modest cognitive benefits. NMDA receptor antagonists, like memantine, regulate glutamate activity to prevent excitotoxicity, which can damage neurons. These treatments are crucial for AD patients as they help manage symptoms, improve cognitive function, and potentially slow disease progression, enhancing overall quality of life.