Open-Label Extension Protocol to SNK01-AD01 Study
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug
Behavioral Research Specialists, LLC
Glendale, California, United States
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0
Evaluate the safety and tolerability of SNK01 assessed by labs, PE and AEs
Time frame: 1 Year
Preliminary efficacy in cognitive assessment scores of CDR-SB
Measure changes in cognitive assessment of CDR-SB from baseline
Time frame: 1 Year
Preliminary efficacy in cognitive assessment scores of MMSE
Measure changes in cognitive assessment of MMSE from baseline
Time frame: 1 Year
Preliminary efficacy in cognitive assessment scores of NPI
Measure changes in cognitive assessment of NPI from baseline
Time frame: 1 Year
Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe
Measure changes in cognitive assessment of ADCS-ADL-Severe from baseline
Time frame: 1 Year
Preliminary efficacy in cognitive assessment scores of ADAS-Cog
Measure changes in cognitive assessment of ADAS-Cog from baseline
Time frame: 1 Year
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