Antiviral Therapy for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byDavangere Devanand, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Columbia University

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Davangere Devanand, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for mild Alzheimer's patients who test positive for herpes simplex virus. They must be able to consent, have a caregiver, and not have severe medical conditions or other major neurological disorders. Participants should not have had significant radiation exposure in the last year or take high doses of benzodiazepines.

Inclusion Criteria

Your test score for memory and thinking skills should be between 18 and 28 out of 30.

I have mild memory issues and tests show signs of Alzheimer's disease.

I am taking medications for memory issues or mood that are not high dose benzodiazepines.

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Exclusion Criteria

My kidney function is reduced with a GFR less than 44 ml/min.

I have had a stroke and still experience its effects.

I do not have Parkinson's, MS, CNS infection, Huntington's, or ALS.

See 14 more

Treatment Details

Interventions

Placebo (Other)
Valacyclovir (Anti-viral)

Trial OverviewThe study tests if Valacyclovir (an anti-viral drug) at 4 grams per day can treat Alzheimer's disease compared to a placebo over 18 months. It involves 130 participants with mild AD, split into two groups by chance, one receiving the drug and the other a placebo.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: ValacyclovirActive Control1 Intervention

The oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day.

Group II: PlaceboPlacebo Group1 Intervention

The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day.