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Alzheimer DiseasePhase 2VALZ-PilotNCT02997982

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

A Phase 2 study testing Valaciclovir 500Mg Tablet in people with Alzheimer Disease and Mild Cognitive Impairment, run by Hugo Lovheim at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Valaciclovir 500Mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesSweden
Study dates
Dec 2016to 4 Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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. At least one brain imaging examination should have been done (CT, MR, SPECT or PET/CT) and at least one objective finding should support the diagnosis beyond specific medical history. Reduced perfusion or reduced metabolism bilaterally temporally, hippocampal atrophy or pathological markers for Alzheimer's disease in cerebrospinal fluid is such findings. Persons with vascular brain disorders e.g. severe white matter changes or previous brain infarction will not be included but those with white matter changes considered normal for their age can be included.
  • Positive for anti-HSV (Herpes Simplex Virus) Immunoglobulin G (IgG) in plasma, i.e. carrier of HSV.
  • Hetero or Homozygote for allele 4 of gene Apolipoprotein E.
  • Stable over all medication including medication for Alzheimer's disease (rivastigmine, galantamin, donepezil or memantin) for at least one month.
  • No known allergy or oversensitivity against valaciclovir or aciclovir.
  • Ability to independently or by support from relative or other caretaker comply to study drug.

Who cannot join

  • Renal insufficiency with estimated GFR (Glomerular Filtration Rate) ≤ 30 ml/min/1.73m2
  • Ongoing treatment with anticoagulants (Warfarin, low molecular heparin or other anticoagulant agents). Antiplatelet agents in recommended dose are accepted (i.e. Acetylsalicylic acid 75 mgx1)
  • Life expectancy < 1 year due to other comorbidity
  • Ongoing severe somatic condition that might interfere with the patients participation in the study (i.e. ongoing cancer treatment)
  • Ongoing illness that makes exams in a supine position impossible (i.e. severe heart failure, severe back pain).
  • Dementia diagnosis other than Alzheimer's disease, including Vascular dementia.
Show all 12Show fewer
  • Other known neurological/neurodegenerative disorder (i.e. brain tumor, MS (Multiple sclerosis), ALS (amyotrophic lateral sclerosis))
  • Claustrophobia or other contraindication for doing a PET/CT scanning.
  • Depression or other psychiatric illness that requires treatment (i.e. severe psychosis or other illness with equal grade of seriousness)
  • Dementia or cognitive dysfunction to 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 is accepted.
  • Not willing to participate in the study.

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Geriatric Centre, University Hospital in Umeå

    Umeå, Västerbotten County, 90185

  • Memory Clinic, Uppsala University Hospital

    Uppsala

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
Valaciclovir 500Mg Tablet
Keywords
Alzheimer's Disease, Herpes Simplex Virus, HSV, Antiviral Drugs
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Herpes Simplex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Valaciclovir 500Mg TabletDrug

    Also called Valtrex (R)

    Valaciclovir treatment (oral, 500 mg tablets). First week: 500 mg three times daily, second to fourth week: 1000 mg three times daily.

Study groups in NCT02997982
Study groupRoleWhat they receive
Valaciclovir treatmentExperimentalValaciclovir 500Mg Tablet
Receives: Drug: Valaciclovir 500Mg Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cerebrospinal fluid (CSF) Total Tau

    Change in CSF Total Tau between samples taken before and after drug treatment

    Measured: Baseline and treatment day 28

Secondary outcomes (13)

  1. Cerebrospinal fluid (CSF) Neurofilament light chain (NFL)

    Change in CSF NFL between samples taken before and after drug treatment

    Measured: Baseline and treatment day 28

  2. Cerebrospinal fluid (CSF) phosphorylated Tau (p-Tau)

    Change in CSF p-Tau between samples taken before and after drug treatment

    Measured: Baseline and treatment day 28

  3. Cerebrospinal fluid (CSF) Amyloid beta 1-42

    Change in Amyloid beta 1-42 between samples taken before and after drug treatment

    Measured: Baseline and treatment day 28

  4. PET/CT: [18F]-FHBG accumulation within the central nervous system (CNS)

    Can [18F]-FHBG-PET/CT detect replicating HSV infection within the CNS?

    Measured: One week before drug treatment start

  5. PET/CT: Location of [18F]-FHBG accumulation

    Do [18F]-FHBG accumulation locate to brain areas affected in AD?

    Measured: One week before drug treatment start

  6. PET/CT: [18F]-FHBG accumulation

    Change in [18F]-FHBG accumulation after, as compared to before, drug treatment

    Measured: One week before and one week after drug treatment

  7. Mini Mental State Examination - Swedish Revision (MMSE-SR)

    Change in MMSE-SR scores from baseline to after drug treatment

    Measured: Baseline and treatment day 28

  8. Cerebrospinal fluid (CSF) acyclovir concentration

    Cerebrospinal fluid (CSF) acyclovir concentration

    Measured: Treatment day 28

  9. Cerebrospinal fluid (CSF) 9-carboxymethoxymethylguanine (CMMG) concentration

    Concentration of CMMG, main acyclovir metabolite

    Measured: Treatment day 28

  10. Serum acyclovir concentration

    Serum acyclovir concentration

    Measured: Treatment day 28

  11. Serum 9-carboxymethoxymethylguanine (CMMG) concentration

    Concentration of CMMG, main acyclovir metabolite

    Measured: Treatment day 28

  12. Proportion completing the [18F]-FHBG-PET/CT investigations

    Is [18F]-FHBG-PET/CT a feasible examination among persons with Alzheimer's disease

    Measured: For the investigations one week before and one week after drug treatment

  13. Proportion completing the 28 days treatment with valaciclovir at specified doses

    Feasibility of valaciclovir treatment as measured by the number of participants completing the full treatment period at the specified dose

    Measured: Treatment day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion4 Mar 2020
  4. Study completion4 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02997982
Sponsor's protocol ID
UmU-2016-390-31M
Other IDs
2016-002317-22, 2016
Acronym
VALZ-Pilot
Status last verified
Apr 2020
First submitted
6 Dec 2016
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Valaciclovir 500Mg Tablet in people with Alzheimer Disease and Mild Cognitive Impairment, run by Hugo Lovheim at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebrospinal fluid (CSF) Total Tau (time frame: Baseline and treatment day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02997982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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