NCT07502560 · Phase 4 · RECRUITING
A Study to Evaluate the Effect of Recombinant Zoster Vaccine on New Diagnosis of Dementia in an Older Adult Population Aged 76 Years or Older in Finland
This trial is testing whether the Shingrix shingles vaccine can lower the chances of a new dementia diagnosis in adults 76 and older. Half of what makes this interesting is that it builds on earlier observational research suggesting the shingles vaccine might have a protective effect on brain health beyond just preventing shingles. This is a Phase 4 trial, meaning the vaccine is already approved for shingles — this is testing a new potential benefit.
Eligibility criteria
Inclusion Criteria: * Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. Informed consent will include consent to access health register data for participants. * Age 76 years or older at the time of signing the informed consent. Exclusion Criteria: * Prior receipt of a Herpes Zoster (HZ) vaccine. * History of dementia diagnosis prior to enrolment, including confirmed cases or those under investigation. This includes: * History of a confirmed clinical diagnosis of dementia prior to enrolment. * Prior or current use of medications intended to treat dementia. * Current or recent history of cognitive assessments for any memory deficit or suspected dementia before enrolment including investigations that are ongoing or that were inconclusive (but not those for which dementia was conclusively ruled out); mild cognitive impairment on its own without any other information to indicate cognitive decline or dementia will not result in exclusion. * Severely immunocompromised individuals. * Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational product or ongoing participation in trials focused on preventive dementia interventions. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. * Living in a nursing facility.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-05-12