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)

Phase 1

• Conditions: Alzheimer´s disease; MedDRA version: 20.0Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002317-22-SE
• Lead Sponsor: Geriatric Centre, Umeå University hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-23
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified