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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 belowSelect...
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:Select...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 8, 16, 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 8, 16, 24 weeks
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
1,189 Previous Clinical Trials
1,587,841 Total Patients Enrolled
Neal Swerdlow, M.D., Ph.D.Principal InvestigatorUCSD
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently participating in cognitive therapy.I have been diagnosed with Alzheimer's disease by a research center.Your memory and thinking test scores are between 10-22 for MMSE or 15-24 for MOCA.I am between 50 and 83 years old.You can hear sounds at a level of 40 decibels or less at 1000 Hertz.You have used illegal drugs that were not prescribed by a doctor.I am currently taking medications like amantadine, riluzole, or opioids.I have taken memantine and cannot tolerate acetylcholinesterase inhibitors.I have a history of heart or brain vascular issues, seizures, head injuries with unconsciousness, or substance dependence.I do not have any active serious illnesses like heart disease or liver failure.You have a mental or brain-related illness other than Alzheimer's disease.I haven't taken any experimental drugs in the last 30 days.I can walk on my own without help.
Research Study Groups:
This trial has the following groups:- Group 1: Memantine
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.