NCT07228078 · Phase 2 · RECRUITING
Open-Label Extension Protocol to SNK01-AD01 Study
This is an open-label extension of an earlier study, SNK01-AD01. SNK01 is a biological therapy. Everyone who finished the first study can continue receiving it, and researchers keep watching safety and how people do over time. It is a Phase 2 trial, meaning it is testing safety and whether it works, not yet proven or approved. Details are limited so far.
Eligibility criteria
Inclusion Criteria: Participants will be considered eligible for participation in the study if all the following criteria are satisfied: * The participant or their legally authorized representative must be willing and able to give their informed consent in writing and comply with the requirements of this study protocol. Informed consent for participants or their legally authorized representative and caregivers will be obtained before any trial-related activity. (Trial-related activities are any procedure that would not be performed during normal treatment of the subject). * Participants must have a reliable study partner/caregiver (per investigator judgement for instance a family member, partner etc., guardian (must be always the same person)) who is in close contact with the patient, available on call and who is able to contribute to the assessment of the ratings of the functional endpoints at specific study visits. This person will be able to communicate in the language in which the participant is being assessed and should also serve as a backup contact for the study site. * Participants previously completed participation in study SNK01-AD01. Exclusion Criteria: Participants who fulfill any of the following criteria will not be recruited into the study: • Any participant whose safety the investigator considers to be at risk from this trial's intervention.
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 2025-11-13