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Valacyclovir for Mild Cognitive Impairment (VALMCI Trial)
VALMCI Trial Summary
This trial is a Phase II, placebo-controlled, 52-week trial using oral valacyclovir 4 g/day in 50 HSV seropositive, AD biomarker-positive, amnestic mild cognitive impairment (MCI) patients. The purpose is to compare the repurposed drug valacyclovir to placebo in patients with amnestic MCI, in order to address the viral etiology hypothesis of Alzheimer's disease.
VALMCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVALMCI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VALMCI Trial Design
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- You need to test positive for herpes antibodies during screening.I do not have major neurological disorders like Parkinson's or multiple sclerosis.You have a positive amyloid scan or a positive CSF biomarker for Alzheimer's disease.You have thoughts of hurting yourself, or a plan to do so, as determined by a doctor.I am able to understand and make decisions about my treatment.You need to score 23 or higher out of 30 on the Folstein Mini Mental State test.I am between 50 and 95 years old.I have been diagnosed with mild cognitive impairment.You have had a drinking or drug problem in the past 6 months.My medication doses, including for memory issues, have been stable for the last month.My past year's radiation exposure, including this test, won't exceed FDA limits.I have been diagnosed with schizophrenia, bipolar disorder, or major depression.Your blood pressure when sitting is higher than 160/100 mm Hg.Your thyroid stimulating hormone (TSH) levels are higher than 4.94 mlU/L.I have not had a menstrual period for at least 12 months.I have had a stroke and still experience its effects.I do not have any severe, unstable illnesses and my cancer has not been active or spread in the last 12 months.My kidney function is reduced with a GFR less than 44 ml/min.You have serious trouble seeing or hearing that would make it hard for you to do the tests accurately.Your vitamin B12 levels in your blood are lower than they should be.I take 2 mg or more daily of a medication similar to lorazepam.I cannot have an MRI due to metal implants, a pacemaker, or severe claustrophobia.
- Group 1: Placebo
- Group 2: Valacyclovir
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
What is the Valacyclovir medication's standing with the FDA?
"Valacyclovir is a Phase 2 medication, which means that while there is some data supporting its safety, there is none yet for its efficacy. Our team at Power rates it as a 2."
Does this test involve any elderly individuals?
"Eligibility requirements for this study include being between the ages of 50 to 95 years old."
Is this research trial still recruiting patients for participation?
"This is an ongoing clinical trial that was originally posted on February 1st, 2021 according to clinicaltrials.gov. The last update to the posting was on November 3rd, 2022."
What are some things researchers have found after looking into Valacyclovir?
"Currently, 13 clinical trials are investigating the efficacy of Valacyclovir with 1 trial in Phase 3. Many of the studies for Valacyclovir are based in Montreal, Quebec, but there are 204 total locations running clinical trials for Valacyclovir."
What are Valacyclovir's most common benefits?
"Valacyclovir, which is most frequently used to ameliorate the symptoms of genital herpes, can also be effective in treating human immunodeficiency virus type 1 (hiv-1) infection, herpes labialis, and chickenpox."
Are there any prerequisites for subjects in this trial?
"This study is looking for 50 individuals that have experienced cognitive decline. The participants must be between 50-95 years old, postmenopausal, and currently taking cholinesterase inhibitors or memantine. The doses of these medications cannot have changed in the month prior to the study, and any changes made during the study will be documented."
Is this research ground-breaking or has it been done before?
"Valacyclovir has been studied extensively since its initial clinical trial in 2006. The drug has undergone Phase 2 clinical trials and has been approved for use in 13 different countries. Currently, there are 125 active clinical trials for Valacyclovir taking place across 4 countries."
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