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New treatment option for Moderate Alzheimer Disease
Official title Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease
ClinicalTrials.gov ID: NCT06189963
What this study is testing
What is SNK01?
SNK01 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for moderate alzheimer disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- The participant or their legally authorized representative must be willing and able to give their informed consent in writing and comply with the...
- Participants must have a reliable study partner/caregiver (per investigator judgement for instance a family member, partner etc., guardian (must be...
- Patients with diagnosis of Alzheimer's dementia according to the recommendations from the 2011 National Institute on Aging-Alzheimer's Association...
- Age 40 to 85 years old.
- 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...
You likely can't join if
- Substantial concomitant cerebrovascular disease defined as Fazekas Grade 3.
- History of a stroke/intracranial hemorrhage temporally related to the onset of worsening of cognitive impairment in the opinion of the investigator.
- Any substance use disorder that has not been in remission for at least 12 months
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
- Uncontrolled cardiovascular illnesses such as chronic congestive heart failure (with or without oedema), tachycardia, arrhythmias, uncontrolled...
- History of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness within the last year.
See the full eligibility criteria
- 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...
- 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...
- 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.
- Age 40 to 85 years old.
- 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.
- 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...
- Condoms, sponges, foams, gels, diaphragms, or intrauterine device (IUD).
- Hormonal birth control for 30 days prior to administration of the study drug.
- A vasectomized sexual partner.
- Positive evidence for a diagnosis of AD via amyloid positron emission tomography (Amyloid PET) of the brain within the past six months.
- CDR-SB score of ≥ 9.5 and \<16.0.
- Substantial concomitant cerebrovascular disease defined as Fazekas Grade 3.
- History of a stroke/intracranial hemorrhage temporally related to the onset of worsening of cognitive impairment in the opinion of the investigator.
- Any substance use disorder that has not been in remission for at least 12 months
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
- Uncontrolled cardiovascular illnesses such as chronic congestive heart failure (with or without oedema), tachycardia, arrhythmias, uncontrolled hypertension.
- History of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness within the last year.
- Significant pulmonary disease predisposing to hypoxia.
- 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...
- Significant liver disease (for example cirrhosis, active hepatitis B and C, primary or metastatic liver neoplasm).
- 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.
- Significant gastrointestinal disorders (for example gastrointestinal bleeding within the last two years, malabsorption syndromes, post-gastrectomy, or active peptic ulcer disease).
- Immunological disorder such as per investigator judgement clinically significant allergies, Lupus erythematodes, or scleroderma.
- Uncontrolled/Unstable hematological disease (regardless of cause) such as refractory anemia or refractory myelosuppression.
- 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...
- Unstable/uncontrolled major depression or anxiety within the last 12 months.
- History of seizures in the past three years.
- Uncontrolled endocrine disease such as uncontrolled diabetes mellitus or manifest hyperthyroidism, in the opinion of the investigator.
- Severe renal impairment defined as a GFR \< 30 mL/min/1.73 m2 in the screening lab report
- Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or any other infection or active systemic disease.
- Currently being treated with anticoagulants (except aspirin at or below a prophylactic dose).
- 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...
- Any contraindication for performing a brain MRI and/or Amyloid PET scan.
- Any participant whose safety the investigator considers to be at risk from this trial's intervention.
- Participants with any medically unstable/uncontrolled conditions.
- Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Santa Ana, California, United States
- Tarzana, California, United States
- Maitland, Florida, United States
- Orlando, Florida, United States
- Newark, New Jersey, United States
- Albany, New York, United States
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Santa Ana, California, United States; Tarzana, California, United States; Maitland, Florida, United States; Orlando, Florida, United States; Newark, New Jersey, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.