Valacyclovir for Mild Cognitive Impairment

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT04710030
Phase
PHASE2
Status
Completed

Conditions

  • Herpes Simplex 1
  • Herpes Simplex 2
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
50 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
Mar 2026
Primary completion
Oct 23, 2024
Completion
Dec 23, 2024

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Valacyclovir
    Oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day (total dose: 4 grams per day) for 52 weeks.
  • Placebo Comparator: Placebo
    The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day for 52 weeks.

Primary Outcome Measure

Change in Standardized Uptake Value Ratio (SUVR) of (18F-Florbetapir PET) From Week 0 to Week 52. [ Time Frame: Week 0 to Week 52 ]

Locations (1)

FacilityCityStateZIPSite coordinators
New York State Psychiatric InstituteNew YorkNew York10032-

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