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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002317-22 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valaciclovir treatment | Experimental | Valaciclovir 500Mg Tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valaciclovir 500Mg Tablet | Drug | Valaciclovir treatment (oral, 500 mg tablets). First week: 500 mg three times daily, second to fourth week: 1000 mg three times daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal fluid (CSF) Total Tau | Change in CSF Total Tau between samples taken before and after drug treatment | Baseline and treatment day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal fluid (CSF) Neurofilament light chain (NFL) | Change in CSF NFL between samples taken before and after drug treatment | Baseline and treatment day 28 |
| Cerebrospinal fluid (CSF) phosphorylated Tau (p-Tau) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugo Lövheim, M.D., Ph.D. | Umeå University, Umeå, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric Centre, University Hospital in Umeå | Umeå | Västerbotten County | 90185 | Sweden | ||
| Memory Clinic, Uppsala University Hospital |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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|
Change in CSF p-Tau between samples taken before and after drug treatment
| Baseline and treatment day 28 |
| Cerebrospinal fluid (CSF) Amyloid beta 1-42 | Change in Amyloid beta 1-42 between samples taken before and after drug treatment | Baseline and treatment day 28 |
| PET/CT: [18F]-FHBG accumulation within the central nervous system (CNS) | Can [18F]-FHBG-PET/CT detect replicating HSV infection within the CNS? | One week before drug treatment start |
| PET/CT: Location of [18F]-FHBG accumulation | Do [18F]-FHBG accumulation locate to brain areas affected in AD? | One week before drug treatment start |
| PET/CT: [18F]-FHBG accumulation | Change in [18F]-FHBG accumulation after, as compared to before, drug treatment | One week before and one week after drug treatment |
| Mini Mental State Examination - Swedish Revision (MMSE-SR) | Change in MMSE-SR scores from baseline to after drug treatment | Baseline and treatment day 28 |
| Cerebrospinal fluid (CSF) acyclovir concentration | Cerebrospinal fluid (CSF) acyclovir concentration | Treatment day 28 |
| Cerebrospinal fluid (CSF) 9-carboxymethoxymethylguanine (CMMG) concentration | Concentration of CMMG, main acyclovir metabolite | Treatment day 28 |
| Serum acyclovir concentration | Serum acyclovir concentration | Treatment day 28 |
| Serum 9-carboxymethoxymethylguanine (CMMG) concentration | Concentration of CMMG, main acyclovir metabolite | Treatment day 28 |
| Proportion completing the [18F]-FHBG-PET/CT investigations | Is [18F]-FHBG-PET/CT a feasible examination among persons with Alzheimer's disease | For the investigations one week before and one week after drug treatment |
| 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 | Treatment day 28 |
| Uppsala |
| Sweden |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |