CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Valacyclovir hydrochloride 500mg caplet +1 moredrug
Likely dose
Valacyclovir hydrochloride 500mg capletfrom 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/NCT04710030
NCT04710030Phase 2Completed

Anti Viral Treatment in Mild Cognitive Impairment

New York State Psychiatric Institute·interventional·Posted Jan 14, 2021·Updated Mar 31, 2026

In Brief

A Phase 2 clinical trial evaluating Valacyclovir hydrochloride 500mg caplet and Placebo sugar pill caplet for Mild Cognitive Impairment and 2 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Anti-viral treatment in Mild Cognitive Impairment (MCI) 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 (eMCI and lMCI). The trial will directly address the long-standing viral etiology hypothesis of Alzheimer's disease (AD) which posits that viruses, particularly the very common herpes simplex virus-1 (HSV1) and herpes simplex virus-2 (HSV2), may be etiologic or contribute to the pathology of AD. This trial will intervene at an earlier stage (MCI). We will compare the repurposed drug valacyclovir to placebo in patients with amnestic MCI (eMCI and lMCI) in a randomized, double-blind, two-arm parallel group 52-week pilot trial. Our Phase II trial will be the first antiviral drug trial conducted in MCI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 14, 2021
Enrollment StartFeb 1, 2021
Primary CompletionOct 23, 2024
Study CompletionDec 23, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.5 years ago

Interventions

Valacyclovir hydrochloride 500mg capletdrug

Active Comparator

Placebo sugar pill capletdrug

Placebo Comparator