Valacyclovir for Mild Cognitive Impairment

(VALMCI Trial)

Overseen By Cileyn Herrera, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: New York State Psychiatric Institute

Must not be taking: Benzodiazepines

Disqualifiers: Schizophrenia, Bipolar, Major depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 52 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Davangere Devanand, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for people aged 50-95 with Mild Cognitive Impairment who test positive for herpes simplex virus, have certain Alzheimer's disease biomarkers, and can consent for themselves. Women must be postmenopausal. Participants may use some memory medications if doses are stable. Exclusions include major neurological disorders, severe medical conditions, recent cancer or substance abuse, high blood pressure, renal failure, severe sensory impairments, psychiatric diagnoses like schizophrenia or bipolar disorder.

Inclusion Criteria

You need to test positive for herpes antibodies during screening.

You have a positive amyloid scan or a positive CSF biomarker for Alzheimer's disease.

I am able to understand and make decisions about my treatment.

Exclusion Criteria

I do not have major neurological disorders like Parkinson's or multiple sclerosis.

You have thoughts of hurting yourself, or a plan to do so, as determined by a doctor.

You have had a drinking or drug problem in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive oral valacyclovir or placebo for 52 weeks

52 weeks

Visits at Week 0, Week 12, Week 26, and Week 52

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Valacyclovir

Trial Overview The study tests Valacyclovir (an antiviral medication) against a placebo in individuals with Mild Cognitive Impairment to see if it affects the progression of cognitive issues related to Alzheimer's disease. It's a double-blind trial where neither participants nor researchers know who gets the real medicine versus the sugar pill during the year-long study.

How Is the Trial Designed?

Group I: Valacyclovir Active Control 1 Intervention

Oral valacyclovir will be distributed in 500mg caplets. Patients will take 8 caplets per day (total dose: 4 grams per day) for 52 weeks.

Group II: Placebo Placebo Group 1 Intervention

The oral placebo (sugar pill) will be distributed in 500mg caplets. Patients will take 8 caplets per day for 52 weeks.

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+