Treatment of herpesviridae in the treatment of Alzheimer disease

Conditions: Alzheimer disease
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2013-000101-24-FI

Lead Sponsor: niversity of Helsinki

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

-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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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