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NMDA receptor antagonist
Memantine for Preventing Alzheimer's Disease
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights
Study Summary
This trial will test whether memantine hydrochloride can prevent Alzheimer's Disease many years before symptoms appear.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
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Who is running the clinical trial?
University of VirginiaLead Sponsor
756 Previous Clinical Trials
1,245,274 Total Patients Enrolled
Carol Manning, PhDPrincipal InvestigatorProfessor of Neurology
Anelyssa D'Abreu, MDPrincipal InvestigatorAssociate Professor of Neurology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a brain disorder that affects my memory or thinking.My kidneys work well enough (CrCl ≥ 30 mL/min).I haven't had major surgery in the last 8 weeks and don't plan any during the study.I carry one or two copies of the ApoE ε4 gene.My cognitive function is good, with a MOCA score of 27 or above.I have a family member with dementia.I am generally healthy or stable with medication, as confirmed by recent medical exams.I don't have a neurological condition that could confuse my Alzheimer's diagnosis.I am between 50 and 65 years old.I do not have active major organ or system diseases.I am currently receiving treatment for cancer.I take medication that changes the acidity of my urine.I have severe kidney or liver problems.I have no brain conditions that could affect my thinking.I need medication for my condition, such as an AChE inhibitor or specific others.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Memantine hydrochloride
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are seniors within the age range of this clinical experiment?
"The lower and upper age limits set out in the eligibility requirements are 50 years old and 65 years old respectively."
Answered by AI
Are there any other investigations that have focused on Memantine Hydrochloride Tablets?
"Presently, 11 Phase 3 trials are being conducted with Memantine Hydrochloride Tablets in Columbus, Ohio. Additionally, there are 24 ongoing experiments involving the same medication distributed across 294 different medical sites."
Answered by AI
What is the cap on participant numbers in this clinical trial?
"Affirmatively, details on clinicaltrials.gov demonstrate that this trial is actively seeking participants. Originally posted on October 11th 2021, the study was recently updated and seeks to enroll 32 individuals at one medical centre."
Answered by AI
Could you please elaborate on the potential adverse effects of Memantine Hydrochloride Tablets?
"Despite having no clinical efficacy data, Memantine Hydrochloride Tablets received a score of 2 for its demonstrated safety in Phase 2 trials."
Answered by AI
What criteria must potential participants possess to be considered for this medical experiment?
"This clinical trial is seeking 32 participants with a diagnosis of Alzheimer's disease and aged between 50 to 65."
Answered by AI
Is recruitment currently ongoing for this experiment?
"According to clinicaltrials.gov, the trial is actively accepting participants, with initial postings made on October 11th 2021 and latest updates added a year later (October 11th 2022)."
Answered by AI
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