Your session is about to expire
← Back to Search
Antiviral
Valacyclovir for Mild Cognitive Impairment (VALMCI Trial)
Phase 2
Waitlist Available
Led By Davangere Devanand, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient retains capacity to consent for him/herself
Diagnosis of MCI (includes eMCI and lMCI by ADNI criteria)
Must not have
Current diagnosis of other major neurological disorders, including Parkinson's disease, multiple sclerosis, CNS infection, Huntington's disease, and amyotrophic lateral sclerosis
Radiation exposure in the prior 12 months that, together with 18F- Florbetapir will be above the FDA annual radiation exposure threshold
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 12, week 26, week 52
Awards & highlights
All Individual Drugs Already Approved
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.
Who is the study for?
This trial is for people aged 50-95 with Mild Cognitive Impairment who test positive for herpes simplex virus, have certain Alzheimer's disease biomarkers, and can consent for themselves. Women must be postmenopausal. Participants may use some memory medications if doses are stable. Exclusions include major neurological disorders, severe medical conditions, recent cancer or substance abuse, high blood pressure, renal failure, severe sensory impairments, psychiatric diagnoses like schizophrenia or bipolar disorder.
What is being tested?
The study tests Valacyclovir (an antiviral medication) against a placebo in individuals with Mild Cognitive Impairment to see if it affects the progression of cognitive issues related to Alzheimer's disease. It's a double-blind trial where neither participants nor researchers know who gets the real medicine versus the sugar pill during the year-long study.
What are the potential side effects?
Valacyclovir might cause headaches, nausea, stomach pain, vomiting and dizziness. Rarely it could lead to confusion or kidney problems when taken at high doses as in this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to understand and make decisions about my treatment.
Select...
I have been diagnosed with mild cognitive impairment.
Select...
I have not had a menstrual period for at least 12 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have major neurological disorders like Parkinson's or multiple sclerosis.
Select...
My past year's radiation exposure, including this test, won't exceed FDA limits.
Select...
My kidney function is reduced with a GFR less than 44 ml/min.
Select...
I take 2 mg or more daily of a medication similar to lorazepam.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0, week 12, week 26, week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 12, week 26, week 52
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 Cooperative Study- Preclinical Alzheimer Cognitive Composite (PAAC) cognitive composite score from Week 0 to Week 52.
Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-PI (ADCS-ADL-PI) score from Week 0 to Week 52.
Change in accumulation of amyloid plaque (18F-Florbetapir PET) from Screening or Week 0 to Week 52.
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ValacyclovirActive Control1 Intervention
Oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day (total dose: 4 grams per day) for 52 weeks.
Group II: PlaceboPlacebo Group1 Intervention
The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day for 52 weeks.
Find a Location
Who is running the clinical trial?
New York State Psychiatric InstituteLead Sponsor
478 Previous Clinical Trials
153,923 Total Patients Enrolled
Alzheimer's AssociationOTHER
97 Previous Clinical Trials
42,589 Total Patients Enrolled
Davangere Devanand, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
206 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Valacyclovir
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger