NCT02997982

Feasibility and Effects of Valaciclovir Treatment in Persons With Early Alzheimer's Disease

Feasibility and Effects on Markers in Spinal Fluid in Persons With Early Alzheimer's Disease When Treated With Valaciclovir - Open Fas II Pilot Study (VALZ-Pilot)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Hugo Lovheim · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the effects of Valaciclovir treatment to individuals with Alzheimer's disease or Mild Cognitive Impairment of Alzheimer's Disease Type. It is an open pilot trial where 36 participants will receive 4 weeks of Valaciclovir treatment. Participants will be investigated using different measures before and after the treatment period.

Detailed description

This study investigates the effects of valaciclovir treatment to individuals with Alzheimer's disease (AD) or Mild Cognitive Impairment of Alzheimer's Disease Type. It is an open pilot trial where 36 participants will receive 4 weeks of oral valaciclovir treatment. To find 36 persons fulfilling inclusion criteria, up to 120 persons will be screened. Important inclusion criteria are Herpes Simplex Virus (HSV) Immunoglobulin G (IgG)-positivity (HSV carriage), Apolipoprotein E allele 4 carriage and sufficient kidney function (estimated glomerular filtration rate above 30 ml/min). All participants must give their informed consent to participation. The valaciclovir dose will be 500 mg three times daily the first week and 1000 mg three times daily week 2-4. Participants will be investigated using different measures before and after the treatment period: Mini Mental State Examination to assess cognitive function, Cerebrospinal fluid biomarkers of Alzheimer's disease and \[18F\]-FHBG-PET/CT (9-\[4-\[18F\]fluoro-3-(hydroxymethyl)butyl\]guanine positron emission tomography/computed tomography)) to possibly indicate active HSV infection within the central nervous system.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Herpes Simplex

Interventions

Type	Name	Description
DRUG	Valaciclovir 500Mg Tablet	Valaciclovir treatment (oral, 500 mg tablets). First week: 500 mg three times daily, second to fourth week: 1000 mg three times daily.

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-03-04
• Completion: 2020-03-04
• First posted: 2016-12-20
• Last updated: 2020-04-03

Locations

2 sites across 1 country: Sweden