Menschen, bei denen Alzheimer im Frühstadium diagnostiziert wurde und denen das Herpesmedikament Valaciclovir verabreicht wurde, erlebten tatsächlich einen stärkeren kognitiven Rückgang als diejenigen, denen ein Placebo verabreicht wurde | Valaciclovir-Behandlung der frühen symptomatischen Alzheimer-Krankheit: Die randomisierte klinische VALAD-Studie

Highlights from the news article:

>Researchers at Columbia University published the disappointing results of their randomized trial this week. Cognition in people with diagnosed herpes and early Alzheimer’s did not improve with antiviral treatment compared to a placebo—in fact, the treatment group actually fared worse. Though the findings don’t necessarily rule out a genuine link between some viral infections and Alzheimer’s, the use of these drugs for treating dementia shouldn’t be encouraged, according to outside experts.
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>The randomized, controlled trial involved 120 participants diagnosed with probable Alzheimer’s or mild cognitive impairment likely to develop into Alzheimer’s. They also tested positive for antibodies to herpes simplex virus type 1 or 2. HSV-1 is the primary cause of cold sores, while HSV-2 most often causes genital herpes, but either type can cause the other.
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>For 18 months, the participants were randomized to take a daily placebo or valacyclovir (better known by the brand name Valtrex), a standard treatment used to manage HSV and other kinds of herpesvirus infections.
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>By the study’s end, the treatment group saw a significantly worse progression of cognitive decline compared to the placebo. Based on imaging tests, the treatment also didn’t improve people’s brain markers or their overall neurodegeneration.
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>As damning as these results are, they don’t completely sink the idea that viruses can contribute to at least some cases of Alzheimer’s.
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>It often takes time before the damaging brain changes seen in Alzheimer’s become apparent. And by the time someone is experiencing Alzheimer’s symptoms, it might simply be too late to slow the disease’s progression by treating infections that knocked the first domino down, so to speak, many years earlier.
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>“Might there be a role at the population level for vaccination? Maybe?,” said Knopman, who wrote an editorial accompanying the study in JAMA.

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Journal link: [Valacyclovir Treatment of Early Symptomatic Alzheimer Disease: The VALAD Randomized Clinical Trial](https://jamanetwork.com/journals/jama/fullarticle/2842964?guestAccessKey=2b0c16c4-ad92-4700-ad9b-ae3dea904157&utm_source=for_the_media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=121725)

Abstract:

>**Importance** Neuroscientific, epidemiological, and electronic health record studies implicate herpes simplex virus (HSV) as potentially etiological for Alzheimer disease (AD).
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>**Objective** To compare the efficacy and adverse effects of valacyclovir vs placebo in participants with early symptomatic AD and HSV seropositivity (HSV-1 or HSV-2).
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>**Design, Setting, and Participants** This randomized clinical trial included adults with a clinical diagnosis of probable AD or a clinical diagnosis of mild cognitive impairment with positive biomarkers for AD, a positive serum antibody test (IgG or IgM) for HSV-1 or HSV-2, and a Mini-Mental State Examination score of 18 to 28. The trial was conducted at 3 US outpatient clinics specializing in memory disorders. Recruitment occurred from January 2018 to May 2022; the last follow-up occurred in September 2024.
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>**Intervention** Either 4 g/d of valacyclovir (n = 60) or matching placebo (n = 60).
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>**Main Outcomes and Measures** The primary outcome was least-squares mean (LSM) change at 78 weeks in the 11-item Alzheimer’s Disease Assessment Scale Cognitive (ADAS-Cognitive) Subscale score (range, 0-70; higher scores indicate greater impairment). The secondary outcomes were LSM change in the Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) Scale score; LSM change in the 18F-florbetapir amyloid positron emission tomography (PET) standardized uptake value ratio (SUVR; higher scores indicate higher amyloid levels) for 6 brain regions (medial orbitofrontal, anterior cingulate, parietal lobe, posterior cingulate, temporal lobe, and precuneus); and LSM change in 18F-MK-6240 tau PET medial temporal SUVR (higher scores indicate higher tau levels) for 4 brain regions (amygdala, hippocampus, entorhinal, and parahippocampus). The frequency of adverse events was the safety outcome.
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>**Results** Of the 120 participants (mean age, 71.4 [SD, 8.6] years; 55% were female), 93 (77.5%) completed the trial. At 78 weeks, the LSM change in the 11-item ADAS-Cognitive Subscale score was 10.86 (95% CI, 8.80 to 12.91) in the valacyclovir group vs 6.92 (95% CI, 4.88 to 8.97) in the placebo group, indicating greater cognitive worsening with valacyclovir than placebo (between-group difference, 3.93 [95% CI, 1.03 to 6.83]; P = .01). The LSM change in the ADCS-ADL Scale score at 78 weeks was −13.78 (95% CI, −17.00 to −10.56) in the valacyclovir group vs −10.16 (95% CI, −13.37 to −6.96) in the placebo group (between-group difference, −3.62 [95% CI, −8.16 to 0.93]). At 78 weeks, the LSM change in the 18F-florbetapir amyloid PET SUVR was 0.03 (95% CI, −0.04 to 0.10) in the valacyclovir group vs 0.01 (95% CI, −0.06 to 0.08) in the placebo group (between-group difference, 0.02 [95% CI, −0.08 to 0.12]). The LSM change in the 18F-MK-6240 tau PET medial temporal SUVR at 78 weeks was 0.07 (95% CI, −0.06 to 0.19) in the valacyclovir group vs −0.04 (95% CI, −0.15 to 0.07) in the placebo group (between-group difference, 0.11 [95% CI, −0.06 to 0.28]). The most common adverse events were elevated serum creatinine level (5 participants [8.3%] in the valacyclovir group vs 2 participants [3.3%] in the placebo group) and COVID-19 infection (3 [5%] vs 2 [3.3%], respectively).
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>**Conclusions and Relevance** Valacyclovir was not efficacious with cognitive worsening for the primary outcome and it is not recommended to treat individuals with early symptomatic AD and HSV seropositivity.

Infected neurons pop like a balloon and take out everything it did with it, good thing common colds aren’t neuropathic right?