Open-Label Extension Protocol to SNK01-AD01 Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SNK01.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety, Tolerability and Exploratory Efficacy of SNK01 in Participants With Alzheimer's Disease (Study SNK01-AD02)
Overview
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
- Biological SNK01
SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug
Primary outcome measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: 1 Year]
Secondary outcome measures (5)
- Preliminary efficacy in cognitive assessment scores of CDR-SB [Time frame: 1 Year]
- Preliminary efficacy in cognitive assessment scores of MMSE [Time frame: 1 Year]
- Preliminary efficacy in cognitive assessment scores of NPI [Time frame: 1 Year]
- Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe [Time frame: 1 Year]
- Preliminary efficacy in cognitive assessment scores of ADAS-Cog [Time frame: 1 Year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Behavioral Research Specialists, LLC — Glendale
Identifiers
NCT: NCT07228078 · SNK01-AD02