Anti-viral Therapy in Alzheimer's Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Columbia University
Study ID
NCT03282916
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Valacyclovir — DRUG
    Valacyclovir hydrochloride 500mg caplet
  • Placebo — DRUG
    Placebo sugar pill 500mg caplet

Study Details

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.

Key Dates

Start date
Feb 12, 2018
Status verified
Sep 2025
Primary completion
Sep 5, 2024
Completion
Sep 5, 2024

Study Design

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

Arms

  • Active Comparator: Valacyclovir
    The oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day.
  • Placebo Comparator: Placebo
    The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day.

Primary Outcome Measure

Alzheimer's Disease Assessment Scale - Cognition (ADAS-COG11, Modified Version) Score [ Time Frame: Baseline, Week 78 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Banner Alzheimer's Institute (BAI)PhoenixArizona85006-
New York State Psychiatric InstituteNew YorkNew York10032-
New York University School of MedicineNew YorkNew York10016-

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Banner Alzheimer's Institute (BAI)· Phoenix, AZNew York State Psychiatric Institute· New York, NYNew York University School of Medicine· New York, NY

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