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NCT04710030 · ClinicalTrials.gov registry record · Phase 2
Valacyclovir for Mild Cognitive Impairment
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT04710030: Completed Phase 2 study, sponsored by New York State Psychiatric Institute.
NCT04710030 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04710030, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
18F-Florbetapir PET imaging is hypothesized to show amyloid accumulation in sum of six ROIs (cerebellar gray matter reference) that are known to show increased uptake in AD: medial orbital frontal, anterior cingulate, parietal, temporal, posterior cingulate, precuneus.
Interventions
- DRUG Valacyclovir hydrochloride 500mg caplet
- DRUG Placebo sugar pill caplet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2024-12-23 |
| Phase | Phase 2 |
What the finished NCT04710030 record still lists
NCT04710030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Valacyclovir hydrochloride 500mg caplet is the first listed.
NCT04710030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04710030 about?
NCT04710030 is a clinical study titled "Valacyclovir for Mild Cognitive Impairment". 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...
What is the current status of trial NCT04710030?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2021-02-01. Estimated completion is 2024-12-23.
What interventions are being tested in trial NCT04710030?
The interventions under investigation include: Valacyclovir hydrochloride 500mg caplet (DRUG), Placebo sugar pill caplet (DRUG).
Who is sponsoring clinical trial NCT04710030?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04710030's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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