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    Summary
    EudraCT Number:2016-002317-22
    Sponsor's Protocol Code Number:VALZ-Pilot
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2016-002317-22
    A.3Full title of the trial
    Feasibility and effects on markers in spinal fluid in persons with early Alzheimer's disease when treated with Valaciklovir - open Fas II pilot study (VALZ-Pilot)
    Genomförbarhet och effekt på markörer I ryggmärgsvätska av behandling med Valaciklovir till personer med tidig Altzheimers sjukdom- öppen Fas II pilot studie (VALZ- pilot)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Feasibility and effects on markers in spinal fluid in persons with early Alzheimer's disease when treated with Valaciklovir - open Fas II pilot study (VALZ-Pilot)
    Genomförbarhet och effekt på markörer I ryggmärgsvätska av behandling med Valaciklovir till personer med tidig Altzheimers sjukdom- öppen Fas II pilot studie (VALZ- pilot)
    A.3.2Name or abbreviated title of the trial where available
    VALZ-Pilot
    VALZ-Pilot
    A.4.1Sponsor's protocol code numberVALZ-Pilot
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGeriatric Centre, Umeå University hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVästerbottens läns landsting
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportUmeå Universtitet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUmeå University hospital
    B.5.2Functional name of contact pointHugo Lövheim
    B.5.3 Address:
    B.5.3.1Street AddressUmeå University hospital
    B.5.3.2Town/ cityUmeå
    B.5.3.3Post code90185
    B.5.3.4CountrySweden
    B.5.4Telephone number0046907850000
    B.5.6E-mailhugo.lovheim@umu.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Valtrex
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Smith Kline
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVALACICLOVIR
    D.3.9.1CAS number 124832-26-4
    D.3.9.4EV Substance CodeSUB00003MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name[18F]-FHBG
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN9-[4-[18]F-Fluoro-3(hydroxymethyl)butyl]guaine
    D.3.9.2Current sponsor code9-[4-[18]F-Fluoro-3(hydroxymethyl)butyl]guaine
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer´s disease
    E.1.1.1Medical condition in easily understood language
    Alzheimer´s disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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 evaluate if [18F]-FHBG-PET/CT can be used to show replicating HSV in the brain at early Alzheimer’s disease.
    Another primary objective is to evaluate safety and feasibility for the thorough examinations and treatment.
    Primär målsättning i denna studie är att undersöka förändring i de mätta markörerna för Alzheimers sjukdom från första till andra mätning (före och efter 28 dagars behandling med Valaciklovir), och att undersöka om [18F]-FHBG-PET/CT kan användas för att påvisa replikerande HSV i hjärnan hos personer med tidig Alzheimers sjukdom.
    Ytterligare en primär målsättning är att undersöka säkerhet och genomförbarhet för de ingående undersökningarna och behandlingarna.
    E.2.2Secondary objectives of the trial
    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.
    Sekundära målsättningar är att undersöka ytterligare biomarkörer i CSF samt MMSE-SR före och efter behandling med Valaciklovir och att undersöka vilken koncentration av aciklovir och nedbrytningsprodukten CMMG som uppnås i plasma och CSF under behandling av äldre personer med Alzheimers sjukdom.
    Till de sekundära målsättningarna hör också att undersöka om [18F]-FHBG ansamlas i områden i hjärnan som tidigt påverkas vid Alzheimers sjukdom och om [18F]-FHBG-PET/CT kan användas för att påvisa effekt av Valaciklovir respektive identifiera individer som har särskilt god effekt av behandlingen.
    E.2.3Trial contains a sub-study No
    E.3Principal 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) < 18 will probably not be included.
    Diagnosed with Alzheimer’s disease or mild cognitive impairment due to Alzheimer´s disease where at least one brain imaging examination has been done (CT, MR, SPECT or PET/CT) and where at least one objective finding has shown reduced perfusion or reduced metabolism bilaterally temporally, hippocampus atrophy or pathological markers for Alzheimer’s disease in liquor that supports the diagnose beyond specific medical history. Patients with vascular brain disease e.g. severe white matter changes or previous brain infarction will not be included but patients with white matter changes that are normal for the patients age will be included.
    Positive for anti-HSV (Herpes Simplex Virus) IgG in plasma, i.e. carrier of HSV.
    Hetero or Homozygote for allele 4 of gene Apo lipoprotein E
    Stabile over all medication including medication for Alzheimer’s disease (Rivastigmin, Galantamin, Donepezil eller Memantin) for at least one month.
    No known allergy or oversensitivity against Valaciklovir or Aciklovir.
    Ability to independently or by support from relative or other caretaker comply to study drug.
    Man eller kvinna, ålder ≥ 65 år
    Att personen har förmåga att ta ställning till och lämna ett informerat samtycke till studien, och att sådant samtycke lämnas. Detta innebär att personer med MMSE < ca 18 sannolikt inte kommer i fråga.
    Att personen har diagnosticerats med Alzheimers sjukdom eller mild kognitiv störning av Alzheimertyp, där undersökning med minst en hjärnavbildande teknik utförts (CT, MR, SPECT eller PET/CT), och där minst ett objektivt undersökningsfynd såsom nedsatt perfusion eller metabolism bilateralt temporalt, hippocampusatrofi eller patologiska Alzheimermarkörer i likvor stödjer diagnosen, utöver typisk anamnes. Patienter med vaskulära skador, t.ex. utbredda vitsubstansförändringar eller tidigare infarkter inkluderas ej, men vitsubstansförändringar av sådan grad som normalt ses för åldern utgör inget exklusionskriterium.
    Personen är positiv för anti-HSV IgG i plasma, d.v.s. bär på HSV.
    Personen är hetero- eller homozygot för allel 4 av genen Apolipoprotein E
    Personen har stabil medicinering med övriga läkemedel inklusive eventuella läkemedel mot Alzheimers sjukdom (Rivastigmin, Galantamin, Donepezil eller Memantin) sedan minst en månad.
    Personen ej har känd allergi/överkänslighet mot substansen Valaciklovir eller Aciklovir.
    Att personen själv eller med stöd av anhörig eller vårdare kan antas kunna sköta läkemedelsbehandlingen i studien.
    E.4Principal 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.
    Personen har njursvikt/ nedsatt njurfunktion (beräknat GFR ≤ 30).
    Personen har pågående behandling med antikoagulantia (Warfarin, nya orala antikoagulantia, lågmolekylärt heparin etc. Trombocythämmare i normaldos (t.ex. ASA 75mgx1) är ok)
    Personen har någon instabil eller livshotande sjukdom med beräknad överlevnadstid < 1år.
    Svår pågående somatisk sjukdom som kan förutses försvåra deltagandet i hela studien (t.ex. behandlingskrävande cancer)
    Sjukdom som omöjliggör undersökning i liggande (ex grav hjärtsvikt, svår ryggvärk), enbart studiesite typ A.
    Person med annan demensdiagnos än Alzheimers sjukdom, inklusive vaskulär demens.
    Känd annan allvarlig neurologisk/neurodegenerativ sjukdom (t.ex. hjärntumör, MS, ALS)
    Klaustrofobi eller annan kontraindikation mot undersökning i MR-kamera, enbart studiesite typ A.
    Depression eller annan behandlingskrävande psykiatrisk sjukdom (psykossjukdom eller liknande allvarlighetsgrad)
    Demens eller kognitiv svikt av sådan grad att ett informerat samtycke ej kan lämnas (motsvarar ca MMSE-SR <18)
    Missbruksanamnes (ex. centralstimulantia eller etyl; nikotinbruk undantaget)
    Ej villig att medverka i studien
    E.5 End points
    E.5.1Primary 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?
    Primärt utfallsmått i denna studie är förändring i hjärnskademarkörerna total-Tau och NFL (neurofilament light chain) för Alzheimers sjukdom från första till andra mätning (före och efter 28 dagars behandling med valaciklovir).
    Är behandling med valaciklovir i dosen 500mg x 3 respektive 1000mg x 3 genomförbar och tolererbar för äldre personer med tidig Alzheimers sjukdom?
    Har patienter med Alzheimers sjukdom replikerande herpesvirus i hjärnan och kan i så fall [18F]-FHBG-PET/CT användas för att påvisa detta?
    Är [18F]-FHBG-PET/CT en säker och genomförbar undersökning för patienter med Alzheimers sjukdom?
    E.5.1.1Timepoint(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)
    E.5.2Secondary 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
    Påverkar behandling med Valaciklovir markörer i ryggmärgsvätska för inflammation respektive markörer för Alzheimers sjukdom? Utöver ovanstående kommer markörerna p-Tau (hyperfosforylerat Tau) och Amyloid beta 1-42 att mätas, samt ett batteri av inflammationsmarkörer.
    Vilken koncentration av aciklovir och CMMG uppnås i CSF och plasma genom behandling med Valaciklovir i dosen 1000mg x 3 hos äldre personer med tidig Alzheimers sjukdom?
    Lokaliserar herpesvirus mätt med [18F]-FHBG-PET/CT till sådana områden i hjärnan som tidigt påverkas vid Alzheimers sjukdom?
    Finns skillnader i effekten av behandling med Valaciklovir beroende på om replikerande herpesvirus kan påvisas i hjärnan med [18F]-FHBG-PET/CT eller ej?
    Kan [18F]-FHBG-PET/CT användas för att påvisa effekt av behandling med Valaciklovir?
    Påverkar behandling med Valaciklovir kognition mätt med MMSE-SR hos personer med tidig Alzheimers sjukdom?
    E.5.2.1Timepoint(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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
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