Actively Recruiting
Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease
Led by NKGen Biotech, Inc. · Updated on 2026-05-14
36
Participants Needed
8
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant or their legally authorized representative must be willing and able to give written informed consent and comply with the study protocol.
- Participants must have a reliable study partner or caregiver in close contact, available on call, and able to assist with functional assessments.
- Diagnosis of Alzheimer's dementia according to 2011 National Institute on Aging-Alzheimer's Association guidelines.
- Age between 40 and 85 years.
- At least 6 years of formal education and fluency in the test language.
- Female participants of childbearing potential must have a negative urine pregnancy test at screening and before first study drug administration.
- Male and female participants of reproductive potential must agree to abstinence or use effective contraception during the study and for 30 days after the last dose.
- Positive amyloid PET scan of the brain within the past six months confirming Alzheimer's Disease.
- Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 9.5 and less than 16.0.
You will not qualify if you...
- Substantial cerebrovascular disease defined as Fazekas Grade 3.
- History of stroke or intracranial hemorrhage related to worsening cognitive impairment.
- Substance use disorder not in remission for at least 12 months.
- History of cancer (except basal cell carcinoma) or cancer treatment within the last 5 years.
- Uncontrolled cardiovascular diseases including congestive heart failure, tachycardia, arrhythmias, or uncontrolled hypertension.
- History of cerebrovascular accident, transient ischemic attack, or unexplained loss of consciousness within the last year.
- Significant pulmonary disease causing risk of low oxygen.
- Significant ischemic heart disease or recent myocardial infarction with residual symptoms.
- Significant liver disease or abnormal liver enzyme levels above three times the upper limit of normal.
- Significant gastrointestinal disorders such as recent bleeding or malabsorption syndromes.
- Immunological disorders like severe allergies, lupus, or scleroderma.
- Uncontrolled hematological diseases such as refractory anemia.
- Neurological or psychiatric conditions impacting cognitive function, including Lewy body dementia, Huntington's disease, Parkinson's disease, schizophrenia, or intellectual disability.
- Unstable or uncontrolled major depression or anxiety in the past 12 months.
- History of seizures in the past three years.
- Uncontrolled endocrine disorders including diabetes or hyperthyroidism.
- Severe kidney impairment with GFR below 30 mL/min/1.73 m2.
- Infection with HIV, hepatitis B or C, or other active systemic diseases.
- Current use of anticoagulants except low-dose aspirin.
- Taking Alzheimer's medications exceeding recommended doses or not stable for 30 days prior to enrollment.
- Contraindications for brain MRI or amyloid PET scans.
- Investigator concerns about participant safety.
- Medically unstable or uncontrolled conditions.
- Suicidal behavior in past 2 years or recent serious suicidal thoughts as defined by specific scales.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
Actively Recruiting
2
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Actively Recruiting
3
Valiance Clinical Research
Tarzana, California, United States, 91356
Withdrawn
4
K2 Medical Research
Maitland, Florida, United States, 32751
Not Yet Recruiting
5
AdventHealth Research Institute
Orlando, Florida, United States, 32804
Actively Recruiting
6
Rutgers Health
Newark, New Jersey, United States, 07107
Not Yet Recruiting
7
Alzheimer's Disease Research Center
Albany, New York, United States, 12208
Actively Recruiting
8
Ottawa Memory Clinic
Ottawa, Ontario, Canada, K1Z 1G3
Not Yet Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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