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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 below
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I am able to understand and make decisions about my treatment.
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I have been diagnosed with mild cognitive impairment.
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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:
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I do not have major neurological disorders like Parkinson's or multiple sclerosis.
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My past year's radiation exposure, including this test, won't exceed FDA limits.
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My kidney function is reduced with a GFR less than 44 ml/min.
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I take 2 mg or more daily of a medication similar to lorazepam.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 12, week 26, week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 12, week 26, week 52 for reporting.

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
98 Previous Clinical Trials
43,354 Total Patients Enrolled
Davangere Devanand, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
206 Total Patients Enrolled

Media Library

Valacyclovir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT04710030 — Phase 2
Mild Cognitive Impairment Research Study Groups: Placebo, Valacyclovir
Mild Cognitive Impairment Clinical Trial 2023: Valacyclovir Highlights & Side Effects. Trial Name: NCT04710030 — Phase 2
Valacyclovir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04710030 — Phase 2
~10 spots leftby Dec 2025
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