CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Valacyclovir +1 moredrug
Likely dose
Valacyclovir 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03282916
NCT03282916Phase 2Completed
CompareCT.gov

Anti-viral Therapy in Alzheimer's Disease

Columbia University·interventional·Posted Sep 14, 2017·Updated Sep 25, 2025

In Brief

A Phase 2 clinical trial evaluating Valacyclovir and Placebo for Alzheimer Disease and 2 related conditions. Completed, enrolled 120 participants across 3 sites.

Detailed Summary

Anti-viral therapy in Alzheimer's disease will investigate the efficacy of treating patients with mild Alzheimer's disease with the U.S.A marketed generic anti-viral drug Valtrex (valacyclovir, 500mg oral tablet). Valacyclovir, titrated to 4 grams per day, repurposed to treat Alzheimer's disease, will be compared to matching placebo in the treatment of 130 mild AD patients (65 valacyclovir, 65 placebo) who test positive for herpes simplex virus-1 (HSV1) or herpes simplex virus-2 (HSV2). The study will be a randomized, double-blind, 18-month Phase II proof of concept trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease, Herpes Simplex 1, Herpes Simplex 2
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute on Aging (NIA)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 14, 2017
Enrollment StartFeb 12, 2018
Primary CompletionSep 5, 2024
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 8.8 years ago

Interventions

Valacyclovirdrug

Valacyclovir hydrochloride 500mg caplet

Placebodrug

Placebo sugar pill 500mg caplet