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Antiviral Therapy for Alzheimer's Disease
Phase 2
Waitlist Available
Led By Davangere Devanand, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For patients diagnosed with Mild Cognitive Impairment and CDR score of 0.5, if these patients have biomarkers of AD neuropathology with either a positive amyloid PET scan, positive fluorodeoxyglucose (FDG) PET scan of the brain, or positive findings for AD in CSF, they will be eligible for the study.
Males and females. Females must be postmenopausal defined as 12 consecutive months without menstruation.
Must not have
Renal failure as determined by an estimated Glomerular Filtration Rate (GFR) < 44 ml/min/1.73m2.
Clinical stroke with residual neurological deficits.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 12, week 26, week 52, week 78
Summary
This trial will study whether the U.S.A marketed generic anti-viral drug Valtrex (valacyclovir, 500mg oral tablet) can be repurposed to treat Alzheimer's disease.
Who is the study for?
This trial is for mild Alzheimer's patients who test positive for herpes simplex virus. They must be able to consent, have a caregiver, and not have severe medical conditions or other major neurological disorders. Participants should not have had significant radiation exposure in the last year or take high doses of benzodiazepines.
What is being tested?
The study tests if Valacyclovir (an anti-viral drug) at 4 grams per day can treat Alzheimer's disease compared to a placebo over 18 months. It involves 130 participants with mild AD, split into two groups by chance, one receiving the drug and the other a placebo.
What are the potential side effects?
Valacyclovir may cause side effects like headache, nausea, stomach pain, vomiting, dizziness. Rarely it might lead to serious issues such as kidney problems or increased risk of bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mild memory issues and tests show signs of Alzheimer's disease.
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I am a man or a woman who has not had a period for at least 12 months.
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I have been diagnosed with Alzheimer's disease.
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I cannot have an MRI due to metal implants, a pacemaker, or severe claustrophobia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is reduced with a GFR less than 44 ml/min.
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I have had a stroke and still experience its effects.
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I do not have a sudden, severe, and unstable illness.
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I do not have Parkinson's, MS, CNS infection, Huntington's, or ALS.
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I have not been exposed to radiation levels above the FDA limit in the last year.
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I have been diagnosed with a mental health condition like schizophrenia or major depression.
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My dementia is not primarily caused by Alzheimer's disease.
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I do not have thrombotic thrombocytopenic purpura or hemolytic uremic syndrome.
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I take 2 mg or more daily of a medication similar to lorazepam.
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I cannot have an MRI due to metal implants, a pacemaker, or severe claustrophobia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0, week 12, week 26, week 52, week 78
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 12, week 26, week 52, week 78
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Alzheimer's Disease Assessment Scale - Cognition (ADAS-COG11, modified version) scores from baseline to 78 weeks.
Secondary study objectives
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scores from baseline to 78 weeks.
Change in total 18F-Florbetapir brain uptake from baseline to 78 weeks.
Change in total 18F-MK-6240 brain uptake from baseline to 78 weeks.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ValacyclovirActive Control1 Intervention
The oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day.
Group II: PlaceboPlacebo Group1 Intervention
The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day.
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,060 Total Patients Enrolled
New York State Psychiatric InstituteLead Sponsor
478 Previous Clinical Trials
153,853 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,422 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is reduced with a GFR less than 44 ml/min.Your test score for memory and thinking skills should be between 18 and 28 out of 30.I have had a stroke and still experience its effects.I have mild memory issues and tests show signs of Alzheimer's disease.I am taking medications for memory issues or mood that are not high dose benzodiazepines.I do not have Parkinson's, MS, CNS infection, Huntington's, or ALS.I have not been exposed to radiation levels above the FDA limit in the last year.I am a man or a woman who has not had a period for at least 12 months.I can make my own medical decisions or appoint someone to do so.I have been diagnosed with a mental health condition like schizophrenia or major depression.I do not have a severe cold, smoke heavily, or have a lifelong inability to smell.I do not have a sudden, severe, and unstable illness.My dementia is not primarily caused by Alzheimer's disease.I do not have thrombotic thrombocytopenic purpura or hemolytic uremic syndrome.Your sitting blood pressure is higher than 160/100 mm Hg.I take 2 mg or more daily of a medication similar to lorazepam.You have very bad vision or hearing that would stop you from doing the tests correctly.You have a current cold, smoke a lot, or have a low score on a smell test.Your score on the Modified Hachinski scale is higher than 4.I cannot have an MRI due to metal implants, a pacemaker, or severe claustrophobia.Your vitamin B12 levels in the blood are too low.You currently have thoughts of harming yourself and have a plan to do so, according to a doctor's evaluation.You have had problems with alcohol or drugs in the past 6 months.You need to have a positive test for antibodies to the herpes simplex virus (HSV1 or HSV2) during screening. If the test results are uncertain, you will need to repeat the test within 6 weeks.You have mild dementia, with a score of 1 on the Clinical Dementia Rating (CDR).I have been diagnosed with Alzheimer's disease.I cannot have an MRI due to metal implants, a pacemaker, or severe claustrophobia.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Valacyclovir
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.
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