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Antiviral Therapy for Alzheimer's Disease
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Placebo
- Group 2: Valacyclovir
- 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
Are there opportunities for new patients to enroll in this trial?
"The listing for this study on clinicaltrials.gov indicates that it is no longer recruiting patients. The trial was originally posted on February 12th, 2018 and was last edited on November 3rd, 2020. There are currently 601 other trials that are actively looking for participants."
Does age restrict who can and cannot participate in this opportunity?
"According to the study's inclusion criteria, eligible participants must be between 50-95 years old."
Are there any similar studies to compare this one to?
"Valacyclovir has been the focus of 13 clinical trials spread out over 4 countries and 125 cities. The first ever study was sponsored by Millennium Pharmaceuticals, Inc. in 2006 and only involved 46 people. It completed Phase 2 drug approval stages. A total of 18,341 have been completed since then."
Could I potentially enroll in this experiment?
"This clinical trial is recruiting 120 patients with Alzheimer's disease between the ages of 50 and 95. The most important criteria for candidates are as follows: male or female, postmenopausal (defined as 12 consecutive months without menstruation), a diagnosis of probable Alzheimer's disease by NIA clinical diagnostic criteria, Folstein Mini Mental State (MMSE) score 18 to 28 out of 30, Clinical Dementia Rating (CDR) score of 1 (mild dementia), positive for serum antibodies to HSV1 or HSV2."
For what medical purposes is Valacyclovir most often prescribed?
"Valacyclovir can be used to manage and treat symptoms associated with genital herpes, human immunodeficiency virus type 1 (hiv-1) infection, and herpes labialis."
Could you provide a brief overview of other similar studies to Valacyclovir?
"Valacyclovir is being trialed in 13 separate ongoing studies, with one of them having reached Phase 3. Many of these trials are taking place in Montreal, but there are a total of 204 research centres running these clinical tests for Valacyclovir."
Are there any known dangers of taking Valacyclovir?
"While Phase 2 trials are promising, as they offer some data supporting safety, there is currently a lack of evidence for efficacy. Therefore, our team has estimated a score of 2."
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