drugset / Trial / NCT03282916
Anti-viral Therapy in Alzheimer's Disease
Phase 2
Completed
120 enrolled
Columbia University
National Institute on Aging (NIA) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2018-02-12
- Primary completion
- 2024-09-05
- Completion
- 2024-09-05
Publications
- Devanand DP, Wisniewski T, Razlighi Q, Qian M, Wei R, Andrews HF, Acosta EP, Bell KL, Pelton GH, Deliyannides D, Perrin AC, Caccappolo E, Gershon AA, Prasad KM, Kreisl WC, Mintz A, Huey ED. Valacyclovir Treatment of Early Symptomatic Alzheimer Disease: The VALAD Randomized Clinical Trial. JAMA. 2026 Feb 10;335(6):511-522. doi: 10.1001/jama.2025.21738.
- Devanand DP, Andrews H, Kreisl WC, Razlighi Q, Gershon A, Stern Y, Mintz A, Wisniewski T, Acosta E, Pollina J, Katsikoumbas M, Bell KL, Pelton GH, Deliyannides D, Prasad KM, Huey ED. Antiviral therapy: Valacyclovir Treatment of Alzheimer's Disease (VALAD) Trial: protocol for a randomised, double-blind,placebo-controlled, treatment trial. BMJ Open. 2020 Feb 6;10(2):e032112. doi: 10.1136/bmjopen-2019-032112.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Valacyclovir | Unknown | 4 g | Oral |