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VALZ-Pilot

Phase II trials

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Study Information

Scientific title

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

Study sponsor

Hugo Lovheim

Disease

Alzheimer’s disease

Phase

Phase II

Information about the drug that will be tested in the study

Name of drug

Valaciclovir

Administration

One to two oral tablets taken three times daily

Is the drug already on the market for another medical condition?

Yes for the treatment of herpes simplex and herpes zoster.

Will all participants receive the same drug?

All participants will receive a tablet of 500mg the first week and then two tablets of 500 mg week 2-4.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the effects of Valaciclovir treatment in people with Alzheimer's disease or mild cognitive impairment of Alzheimer's disease.

How long will the treatment last? 

1 month

What will your involvement entail?

During the study, participants will be asked to:

  • Undertake CSF examination (spinal tap) and brain scans (PET)
  • Complete a memory test (MMSE) to assess cognitive function.

Further information on the number of visits can be obtained from the study team.  

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be 65 years and older
  • Have a score of about 18 points or more in the MMSE test (a test about your memory). This would suggest that the person has an impairment in their memory.
  • Have results of brain scans consistent with the clinical diagnosis of Alzheimer’s disease or mild cognitive impairment due to Alzheimer's disease
  • Have the Herpes Simplex Virus (measured with blood test after inclusion)
  • Have the Apolipoprotein E allele 4 carriage (fat-binding protein implicated in Alzheimer's disease) (measured with blood test after inclusion)
  • If the person is taking medication including medication for Alzheimer's disease (rivastigmine, galantamin, donepezil or memantine), the dosing regimen must have been stable for at least one month
  • Have no allergy against valaciclovir
  • Have an ability to comply independently the study or have a study partner who has a sufficient contact with the participant.

Who cannot participate in the study?

Exclusion criteria include:

  • Renal disorder
  • Currently taking anticoagulants
  • A disease or a medical condition that may interfere with the safety or study assessments including cancer and heart failures
  • Any other type of dementia and neurological disease that is not Alzheimer’s disease (including vascular dementia, brain tumor, multiple sclerosis)
  • Major depressive episode or other psychiatric illness that require treatment
  • History of alcohol or drug abuse

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Where and when will the study be conducted?

European countries involved in the trial

  • Sweden

Estimated start date of recruitment

December 2016

Information for your doctor

EudraCT Number

2016-002317-22

Clinicaltrials.gov identifier

NCT02997982

Study contact information

Hugo Lövheim +46702979499

hugo.lovheim@umu.se

Link to full text

https://clinicaltrials.gov/ct2/show/NCT02997982

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on January 2019.

The pharmaceutical company running this trial has reviewed this document.

This document has been reviewed by a member of the European Working Group of People with Dementia.

 

 
 

Last Updated: Thursday 07 February 2019

 

 
  • Acknowledgements

    Alzheimer Europe's Clinical Trial Watch received funding under an operating grant from the European Union’s Health Programme (2014–2020).
  • European Union
 
 

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