Open-Label Extension Protocol to SNK01-AD01 Study

NKGen Biotech

Status and phase

Enrolling

Phase 2

Conditions

Alzheimer Disease

Treatments

Biological: SNK01

Study type

Interventional

Funder types

Industry

Identifiers

NCT07228078

SNK01-AD02

Details and patient eligibility

About

Open-Label Extension Protocol to SNK01-AD01 Study

Full description

Open-label extension study to assess long-term safety and tolerability of SNK01 administered as an intravenous (IV) infusion every 3 weeks in participants with Alzheimer's Disease

Enrollment

30 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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.