Alzheimer disease
Conditions
Interventions
Trade Name: Valtrex/Valavir (valaciclovir)
Product Name: Valtrex/valavir
Pharmaceutical Form: Tablet
INN or Proposed INN: VALACICLOVIR
CAS Number: 124832-26-4
Sponsors
University of Helsinki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Finnish-speaking - Caregiver with the same address - Living in the Helsinki capital area or in the Oulu region - At least65 years of age - No terminal illness (life expectancy>1 year) - Stable AD (if ongoing AD medication, at least for 3 months) - MMSE-points >15 - HSV-seropositive 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 30
Exclusion criteria
Exclusion criteria: - Allergy towardsvalaciclovir, or other reasons that would hinder takingthe trial medication regularly - Clinically significant interaction between valaciclovir and ongoing medication - Instable or severe clinical condition (cardiovascular disease, cancer) - Untreated depression - Prognosis < 1 year - Symptomsreducingadherence - Severe renal insufficiency (GFR <20, Cockgroft-Gault).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ”Proof-of-concept”-type of trial whether it is possible to slow down cognitive and functional decline among patients with stabile and early Alzheimer disease with valaciclovir - pilot study with valaciclovir only;Secondary Objective: Effect may be especially clear among individuals with a APO E 4 genotype;Primary end point(s): Cognition 8( ADAS-cog) , function (ADCS-ADL) at 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Alzheimer patient: time at home or in institution, NPI, clock test, verbal fluency, CIBIC-plus. Use of health care for the dyad during 24 months. Side-effects. Cost-effectiveness, total mortality. RUD. Caregiver burden (RAND-36).;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Finland
Contacts
Public ContactDepartment of Medicine
University of Helsinki
Outcome results
None listed