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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 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 50 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04710030
The ClinicalTrials.gov registry entry for NCT04710030 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Valacyclovir hydrochloride 500mg caplet is the first listed.
NCT04710030 reports 0 study locations.
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.
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