Alzheimer Disease Clinical Trial
Official title:
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)
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.
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.
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