NCT06189963 Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease
| NCT ID | NCT06189963 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | NKGen Biotech, Inc. |
| Condition | Moderate Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-11-21 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2023-11-21 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are: 1. Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion 2. Can SNK01 administration improve cognitive assessment scores and biomarkers
Eligibility Criteria
Inclusion Criteria: 1. 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 participant). 2. 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. The study partner/caregiver must sign a separate informed consent form which describes their contributions during the study. 3. Patients with diagnosis of Alzheimer's dementia according to the recommendations from the 2011 National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. 4. Age 40 to 85 years old. 5. Patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient or their legally authorized representative and documented by the study investigator. 6. Female participants of childbearing potential must have a negative urine pregnancy test at Screening and Visit 1 before first administration of the study drug. Females of childbearing potential are defined as those who are not surgically sterile or who are not post-menopausal (i.e.: no menses for at least 1 year). Male and female participants of reproductive potential must also agree to abstinence or use acceptable form(s) of effective contraception during the study and for 30 days after the final dose of the study drug. Acceptable methods of contraception include the following: 1. Condoms, sponges, foams, gels, diaphragms, or intrauterine device (IUD). 2. Hormonal birth control for 30 days prior to administration of the study drug. 3. A vasectomized sexual partner. 7. Positive evidence for a diagnosis of AD via amyloid positron emission tomography (Amyloid PET) of the brain within the past six months. 8. CDR-SB score of ≥ 9.5 and \<16.0. Exclusion Criteria: 1. Substantial concomitant cerebrovascular disease defined as Fazekas Grade 3. 2. History of a stroke/intracranial hemorrhage temporally related to the onset of worsening of cognitive impairment in the opinion of the investigator. 3. Any substance use disorder that has not been in remission for at least 12 months 4. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years. 5. Uncontrolled cardiovascular illnesses such as chronic congestive heart failure (with or without oedema), tachycardia, arrhythmias, uncontrolled hypertension. 6. History of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness within the last year. 7. Significant pulmonary disease predisposing to hypoxia. 8. Significant ischemic heart disease, myocardial infarction within the last two years and/or with residual angina, orthopnea, conduction defects (ECG), or any other clinically significant heart disease classified as NYHA III or IV. 9. Significant liver disease (for example cirrhosis, active hepatitis B and C, primary or metastatic liver neoplasm). 10. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening. 11. Significant gastrointestinal disorders (for example gastrointestinal bleeding within the last two years, malabsorption syndromes, post-gastrectomy, or active peptic ulcer disease). 12. Immunological disorder such as per investigator judgement clinically significant allergies, Lupus erythematodes, or scleroderma. 13. Uncontrolled/Unstable hematological disease (regardless of cause) such as refractory anemia or refractory myelosuppression. 14. Neurological disease (such as: Lewy body dementia - primary diagnosis, Huntington's disease, Parkinson's Disease, encephalitis, epilepsy, vascular or multi-infarct dementia, stroke, congenital mental deficiency, multiple sclerosis) and psychiatric disorders (such as schizophrenia, or intellectual disability), or any other disorders impacting cognitive function. 15. Unstable/uncontrolled major depression or anxiety within the last 12 months. 16. History of seizures in the past three years. 17. Uncontrolled endocrine disease such as uncontrolled diabetes mellitus or manifest hyperthyroidism, in the opinion of the investigator. 18. Severe renal impairment defined as a GFR \< 30 mL/min/1.73 m2 in the screening lab report 19. Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or any other infection or active systemic disease. 20. Currently being treated with anticoagulants (except aspirin at or below a prophylactic dose). 21. Participants who are taking medications for AD, like memantine or acetylcholinesterase inhibitors (AChEI) that exceeds the normal recommended dose range or have not achieved a stable dose for the 30 days prior to enrollment. 22. Any contraindication for performing a brain MRI and/or Amyloid PET scan. 23. Any participant whose safety the investigator considers to be at risk from this trial's intervention. 24. Participants with any medically unstable/uncontrolled conditions. 25. Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior). 26. Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06189963 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Moderate Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06189963 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06189963 currently recruiting?
Yes, NCT06189963 is actively recruiting participants. Contact the research team at trials@nkgenbiotech.com for enrollment information.
Where is the NCT06189963 trial being conducted?
This trial is being conducted at Glendale, United States, Santa Ana, United States, Tarzana, United States, Maitland, United States and 4 additional locations.
Who is sponsoring the NCT06189963 clinical trial?
NCT06189963 is sponsored by NKGen Biotech, Inc.. The trial plans to enroll 36 participants.
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