Alzheimer Disease
Conditions
Keywords
Moderate Alzheimer's Disease, AD
Brief summary
Open-Label Extension Protocol to SNK01-AD01 Study
Detailed 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
Interventions
BIOLOGICALSNK01
SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug
Sponsors
NKGen Biotech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 1 Year | Evaluate the safety and tolerability of SNK01 assessed by labs, PE and AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary efficacy in cognitive assessment scores of CDR-SB | 1 Year | Measure changes in cognitive assessment of CDR-SB from baseline |
| Preliminary efficacy in cognitive assessment scores of MMSE | 1 Year | Measure changes in cognitive assessment of MMSE from baseline |
| Preliminary efficacy in cognitive assessment scores of NPI | 1 Year | Measure changes in cognitive assessment of NPI from baseline |
| Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe | 1 Year | Measure changes in cognitive assessment of ADCS-ADL-Severe from baseline |
| Preliminary efficacy in cognitive assessment scores of ADAS-Cog | 1 Year | Measure changes in cognitive assessment of ADAS-Cog from baseline |
Countries
United States
Contacts
Primary ContactStudy Director
Outcome results
None listed