Clinical Study of SNK01 in Participants With 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 1 year
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion 2."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests SNK01 in adults ages 40 to 85 with moderate Alzheimer's disease. It checks whether SNK01 is safe and easy to tolerate when given through a vein every 3 weeks for up to 1 year. It also checks for changes in memory and thinking test scores and signs of disease in the body.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You or your legal representative must give written consent and be able to follow study rules.
- You must have the same reliable caregiver throughout the study. They must stay in close contact, be available by phone, speak the test language, help with study visits, and sign a consent form.
- You must have an Alzheimer's dementia diagnosis that meets the study's guidelines.
- You must be 40 to 85 years old.
- You must have at least 6 years of schooling and speak the test language fluently.
- If you can become pregnant, you must have negative pregnancy tests at screening and before your first dose. If you can have children, you must avoid sex or use approved birth control during the study and for 30 days after the last dose.
- A brain amyloid PET scan within the past 6 months must support your Alzheimer's diagnosis. This scan looks for a protein linked to Alzheimer's.
- Your CDR-SB score, which measures memory, thinking, and daily function, must be at least 9.5 but less than 16.
Who can't join
- Severe disease of the brain's blood vessels; a stroke or brain bleed linked to worsening thinking; or a stroke, mini-stroke, or unexplained fainting in the past year.
- Other brain or mental health disorders that affect thinking; seizures in the past 3 years; uncontrolled depression or anxiety in the past year; or a substance use disorder that has not been in remission for at least 12 months.
- Suicidal behavior in the past 2 years, or thoughts of suicide with intent to act in the past 3 months.
- Cancer history or cancer treatment in the past 5 years, except basal cell skin cancer; HIV, hepatitis B or C, or another infection or active illness affecting the body.
- Serious or uncontrolled heart disease, including a heart attack in the past 2 years; serious lung disease that can cause low oxygen; serious liver disease or certain liver tests over 3 times normal; or severe loss of kidney function.
- Serious stomach or bowel, immune system, or uncontrolled blood disorders; uncontrolled hormone conditions such as diabetes or an overactive thyroid; or any other unstable or uncontrolled medical condition.
- Use of blood thinners, except low-dose aspirin used for prevention. Alzheimer's medicines above the recommended dose range, or doses that have not been stable for at least 30 days before enrollment.
- A medical reason you cannot have a brain MRI or amyloid PET scan, or any reason the study doctor thinks the treatment would put your safety at risk.
Simplified for readability. The official criteria below are what the study team uses.
Official 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).
Study sites (7)
CA
- Behavioral Research Specialists, LLC · Glendale, CA 91206Harry Chung · Study contact · (888) 255-5798 · harry@brstrials.comMore trials in Glendale
- Syrentis Clinical Research · Santa Ana, CA 92705Nikole Bo · Study contact · 714-542-3008 · nbo@syrentis.comMore trials in Santa Ana
- Valiance Clinical Research · Tarzana, CA 91356More trials in Tarzana
FL
- K2 Medical Research · Maitland, FL 32751Adaliz Rodriguez · Study contact · 407-500-5252 · adaliz.rodriguez@k2med.comMore trials in Maitland
- AdventHealth Research Institute · Orlando, FL 32804Ana Chavarro Rendon · Study contact · 407-609-9040 · cfd-sneuroscienceresearch@adventhealth.comMore trials in Orlando
NJ
- Rutgers Health · Newark, NJ 07107Kelly Saverino · Study contact · 973-972-1268 · kcs143@njms.rutgers.eduMore trials in Newark
NY
- Alzheimer's Disease Research Center · Albany, NY 12208Laura Wang · Study contact · 518-426-0575 · lwang@naaresearch.comMore trials in Albany