Clinical trial: Feasibility and Effects of Valaciclovir Treatment in Persons With Early Alzheimer's Disease (NCT02997982)

Eligibility 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) < 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.

        Exclusion Criteria:

          -  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.

          -  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.


Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment