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NCT03282916 · ClinicalTrials.gov registry record · Phase 2
Anti-viral Therapy in Alzheimer's Disease
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT03282916: Completed Phase 2 study, sponsored by Columbia University.
NCT03282916 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03282916, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
The modified ADAS-COG11 is a neuropsychological test used to measure the severity of cognitive dysfunction in Alzheimer's disease. The full range is 0 to 70, where a higher score indicates worse cognition.
Interventions
- DRUG Placebo
- DRUG Valacyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2024-09-05 |
| Phase | Phase 2 |
What the finished NCT03282916 record still lists
NCT03282916 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03282916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03282916 about?
NCT03282916 is a clinical study titled "Anti-viral Therapy in Alzheimer's Disease". 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, wi...
What is the current status of trial NCT03282916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2018-02-12. Estimated completion is 2024-09-05.
What interventions are being tested in trial NCT03282916?
The interventions under investigation include: Placebo (DRUG), Valacyclovir (DRUG).
Who is sponsoring clinical trial NCT03282916?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03282916's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 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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