Alzheimer´s disease MedDRA version: 20.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Valtrex
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VALACICLOVIR
CAS Number: 124832-26-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Geriatric Centre, Umeå University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Man or women, age = 65 years Ability to take a stand and to make and to sign an informed consent to participate in the study. This implies that a person with MMSE (Mini Mental State Examination) =65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: Renal insufficiency, GFR (Glomerular Filtration Rate) = 30 On going treatment with anticoagulants (Warfarin, low molecular heparin or other anticoagulant agents). Antiplatelet agents in recommended dose are accepted (i.e. ASA 75 mgx1) Short life expectancy < 1 year, due to other co morbidity On going severe somatic condition that might interfere with the patients participation in the study (i.e. on going cancer treatment) On going illness that makes exams in a horizontal position impossible (i.e. severe heart failure, severe back pain), only study site type A. Dementia diagnose other than Alzheimer’s disease including Vascular dementia. Other known neurological/neurodegenerative disease (i.e. brain tumour, MS (Multiple sclerosis), ALS (amyotrophic lateral sclerosis)) Claustrophobia or other contraindication for doing an MRI scanning, only study site type A. Depression or other psychiatric illness that requires treatment (i.e. severe psychosis or other illness with equal grade of seriousness) Dementia or cognitive dysfunction in such extent that an informed consent is impossible to obtain corresponding to about MMSE-SR(Mini Mental State Examination-Swedish revision) <18. History of substance abuse (i.e. central nervous system stimulants or alcohol) Nicotine use I accepted. Not willing to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are to evaluate biomarkers in CSF and MMSE-SR before and after treatment with Valaciklovir and to evaluate the concentration of Aciklovir and the breakdown product CMMG in plasma and CSF when treating elderly persons with Alzheimer’s disease Another secondary objective is to investigate if [18F]-FHBG is accumulated in the areas of the brain that are affected in early Alzheimer’s disease and if [18F]-FHBG-PET/CT can be used to demonstrate the effect of Valaciklovir and identify individuals that have an extra good effect by the treatment. ;Primary end point(s): To evaluate change in brain damage markers total-Tau and NFL (Neorofilament light chain) for Alzheimer’s disease between first and second measurement (before and after 28 days of treatment with Valaciklovir)? Is treatment with Valaciklovir 1500 mg/day or 3000 mg/day feasible and tolerated in elderly patients with Alzheimer’s disease? Does patients with Alzheimer’s disease have replicating Herpes Virus in their brain and can [18F]-FHBG-PET/CT be used to show that? Is [18F]-FHBG-PET/CT a safe and feasible examination in patients with Alzheimer’s disease? ;Timepoint(s) of evaluation of this end point: First endpoint -Evaluates by comparing first and second measurement day 1 and day 28. Second endpoint -Evaluates at v 2, v3, v4, v5 and v6, there will also be two telephone calls between v 3 and v4 where adverse events will be recorded. Third endpoint -Evaluates by doing [18F]-FHBG-PET/CT before start of study drug and if necessary at the end of study. Fourth endpoint -Feasibility of PET/CT examination is evaluated when examinations are done (the amount of persons that are able to complete the PET/CT examination, other problems during the examination);Main Objective: Primary objectives in this study are to evaluate change in the measured markers for Alzheimer’s disease between first and second measurement (before and after 28 days of treatment with Valaciklovir), and to eval | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Does treatment with Valaciklovir affect markers for inflammation and markers for Alzheimer’s disease in spinal fluid? There will be done measurement on p-Tau (hyper phosphorylated Tau), Amyloid beta 1-42 and a battery of inflammation markers. What concentration of Aciklovir and CMMG will be reached in CSF and plasma by treatment with Valaciklovir 3000 mg/day in elderly persons with early Alzheimer’s disease? Does Herpes Virus measured with [18F]-FHBG-PET/CT locate in areas of the brain affected by early Alzheimer’s disease? Are there differences in effect of treatment with Valaciklovir depending on if replicating Herpes Virus can be shown in the brain measured with [18F]-FHBG-PET/CT or not? Can [18F]-FHBG-PET/CT be used to show effect of treatment with Valaciklovir. Does treatment with Valaciklovir affect cognition measured with MMSE-SR in persons with early Alzheimer’s disease ;Timepoint(s) of evaluation of this end point: First secondary endpoint -Evaluates Before start o study drug and after 28 days on study drug. Second secondary end point -Evaluates before start of study drug and after 28 days on study drug. Third secondary end point -Evaluates by doing [18F]-FHBG-PET/CT before start of study drug and if necessary after stop of study drug. Fourth secondary end point -Evaluates by doing [18F]-FHBG-PET/CT before start of study drug and if necessary after stop of study drug. Fifth secondary end point -Evaluates by doing [18F]-FHBG-PET/CT before start of study drug and if necessary after stop of study drug. Sixth secondary end point Evaluates by doing MMSE-SR before start of study drug and after 28 days on study drug. | — |
Countries
Sweden
Contacts
Public ContactHugo Lövheim
Umeå University hospital
Outcome results
None listed