Testing SNK01 for moderate Alzheimer's disease

A Phase I/IIa, Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Participants With Moderate Alzheimer's Disease

This study is testing a new treatment called SNK01 to see if it can help people with moderate Alzheimer's disease feel better and improve their thinking skills.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: NKGen Biotech, Inc. (industry)
• Locations: 5 sites (Glendale, California and 4 other locations)
• Trial ID: NCT06189963 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of SNK01, administered as an intravenous infusion every three weeks for up to one year, in participants with moderate Alzheimer's disease. The study will also assess whether SNK01 can improve cognitive assessment scores and relevant biomarkers. Participants will be closely monitored throughout the trial to gather data on the drug's effects and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with moderate Alzheimer's disease who have a reliable caregiver to assist with assessments.

Not a fit: Patients with mild or severe Alzheimer's disease, or those who do not have a reliable caregiver, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with moderate Alzheimer's disease, potentially improving cognitive function.

How similar studies have performed: While this approach is being tested in this specific context, similar studies targeting cognitive improvement in Alzheimer's disease have shown promise, indicating potential for success.

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).

Where this trial is running

Glendale, California and 4 other locations

• Behavioral Research Specialists, LLC — Glendale, California, United States (RECRUITING)
• Syrentis Clinical Research — Santa Ana, California, United States (RECRUITING)
• Valiance Clinical Research — Tarzana, California, United States (RECRUITING)
• AdventHealth Research Institute — Orlando, Florida, United States (RECRUITING)
• Ottawa Memory Clinic — Ottawa, Ontario, Canada (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Study Director

Conditions: Moderate Alzheimer Disease