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NMDA receptor antagonist

Memantine for Alzheimer's Disease

Phase 4
Recruiting
Led By Neal Swerdlow, M.D., Ph.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Alzheimer's Disease Research Center-confirmed diagnosis of AD
Age 50-83 years
Must not have
Active systemic illness (e.g. heart disease, liver failure, renal insufficiency, cancer, HIV, tuberculosis, Hepatitis C)
History of vascular disease, myocardial infarction, cerebrovascular accidents, transient ischemic attack, seizure, head injury with loss of consciousness, substance dependence (including alcohol and Opioid)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 8, 16, 24 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will test whether memantine can improve brain function and reduce symptoms in Alzheimer's Disease.

Who is the study for?
This trial is for people aged 50-83 with Alzheimer's, confirmed by specific tests and having certain cognitive scores. Participants must have a caregiver, be able to walk, hear well at a specific frequency, and be medically stable without serious illnesses or psychiatric conditions other than Alzheimer's.
What is being tested?
The study is examining how memantine affects brain function and symptoms in Alzheimer's patients compared to a placebo (a substance with no active drug). Patients will not know if they're getting the real medication or the placebo.
What are the potential side effects?
While not specified here, common side effects of memantine may include dizziness, headache, confusion, constipation. Placebo typically has no side effects but can cause reactions due to patient expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Alzheimer's disease by a research center.
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I am between 50 and 83 years old.
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I can walk on my own without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any active serious illnesses like heart disease or liver failure.
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I have a history of heart or brain vascular issues, seizures, head injuries with unconsciousness, or substance dependence.
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I have taken memantine and cannot tolerate acetylcholinesterase inhibitors.
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I am currently taking medications like amantadine, riluzole, or opioids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 8, 16, 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 8, 16, 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 weeks
Secondary study objectives
Change from baseline measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 weeks
Other study objectives
Change from baseline measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 weeks

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MemantineActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,575,024 Total Patients Enrolled
Neal Swerdlow, M.D., Ph.D.Principal InvestigatorUCSD

Media Library

Memantine (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03703856 — Phase 4
Alzheimer's Disease Research Study Groups: Memantine, Placebo
Alzheimer's Disease Clinical Trial 2023: Memantine Highlights & Side Effects. Trial Name: NCT03703856 — Phase 4
Memantine (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03703856 — Phase 4
~1 spots leftby Feb 2025