SNK01 for Alzheimer's Disease

Recruiting at 2 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NKGen Biotech, Inc.

Must not be taking: Anticoagulants, AD medications

Disqualifiers: Cerebrovascular disease, Cancer, Cardiovascular, others

Compensation: Varies

Number of Visits: 17

Duration: 52 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants taking Alzheimer's medications like memantine or acetylcholinesterase inhibitors must be on a stable dose for at least 30 days before joining. If you're on other medications, it's best to discuss with the trial team.

What makes SNK01 unique compared to other Alzheimer's disease drugs?

SNK01 is unique because it is being studied for its potential effects on Alzheimer's disease, a condition with limited treatment options, and it may offer a novel approach compared to traditional drugs. While the specific mechanism of SNK01 is not detailed, its development by NKGen Biotech suggests it could involve innovative biotechnology approaches. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for people with moderate Alzheimer's Disease. Participants will receive an intravenous infusion every 3 weeks for up to a year. They must be able to undergo treatment and assessments.

Inclusion Criteria

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

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

I have been diagnosed with Alzheimer's according to the 2011 guidelines.

Exclusion Criteria

I have severe brain blood vessel disease.

I am currently on blood thinners other than low-dose aspirin.

I am on a stable dose of Alzheimer's medication for the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

SNK01 or placebo is administered as an IV infusion every 3 weeks for up to 1 year

52 weeks

17 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• SNK01

Trial Overview The study tests SNK01, administered as an IV infusion every 3 weeks for up to one year, against a placebo. It aims to determine the safety and potential cognitive benefits of SNK01 in treating Alzheimer's.

Participant Groups

Group I: SNK01 Experimental Treatment 1 Intervention

SNK01 will be administered as an IV infusion Q3W for up to 1 year.

Group II: Placebo Placebo Group 1 Intervention

Placebo will be administered as an IV infusion Q3W for up to 1 year.

Who Is Running the Clinical Trial?

NKGen Biotech, Inc.

Lead Sponsor

Trials

7

Recruited

100+

Findings from Research

A model-based meta-analysis using historical data has been developed to better understand the placebo response and disease progression in Alzheimer's disease (AD), which is crucial for designing and interpreting clinical trials.

This analysis has led to the creation of the first-ever quantitative drug development tool for AD, endorsed by both the FDA and EMA, which is now publicly accessible to researchers, enhancing the potential for more effective drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo effect in subjects with cognitive impairment. Ito, K., Romero, K.[2021]

In a study involving 371 Alzheimer's patients, symptom improvement trajectories were similar for both placebo and active drug responders, indicating that the type of treatment may not significantly affect the pattern of symptom relief.

A 10% improvement in symptoms by week 2 was found to be the best predictor of a placebo response by week 8, suggesting that early improvements can help identify patients who may benefit from treatment and reduce trial failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo Effects in the Treatment of Noncognitive Symptoms of Alzheimer's Disease: Analysis of the CATIE-AD Data. Ozawa, C., Roberts, R., Yoshida, K., et al.[2019]

In a 2-year study involving 23 patients with mild-to-moderate Alzheimer's disease who had not responded well to donepezil alone, the combination of donepezil and the traditional Japanese medicine ninjin'yoeito (NYT) led to significant improvements in cognitive function and mood, as measured by specific assessment scales.

While there were no significant differences in overall cognitive scores between the groups, those receiving the combined treatment showed notable enhancements in cognitive assessments and reductions in depression symptoms over time, indicating that NYT may provide additional benefits when used alongside standard Alzheimer's medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ninjin'yoeito, a Kampo (traditional Japanese) medicine, on cognitive impairment and depression in patients with Alzheimer's disease: 2 years of observation. Kudoh, C., Arita, R., Honda, M., et al.[2022]

The study highlights that understanding the placebo response in Alzheimer's disease (AD) is crucial for interpreting clinical trial results, as it can significantly affect the perceived efficacy of treatments.

Baseline cognitive function and study design factors, such as duration and sample size, play important roles in the placebo response, suggesting that recent Phase III trial failures may not be due to inadequate cognitive decline in control groups but rather due to these confounding variables.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding placebo responses in Alzheimer's disease clinical trials from the literature meta-data and CAMD database. Ito, K., Corrigan, B., Romero, K., et al.[2022]

In a review of 23 randomized, placebo-controlled trials for Alzheimer's disease lasting 18 months, no trial demonstrated statistically significant benefits for the test drug, highlighting challenges in detecting modest drug efficacy in this timeframe.

The placebo groups showed a consistent decline in cognitive function (measured by the ADAS-cog) over 18 months, with variability in outcomes suggesting that many patients do not experience significant worsening, complicating the ability to identify effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Alzheimer's disease clinical trials: methods and placebo outcomes. Schneider, LS., Sano, M.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Placebo effect in subjects with cognitive impairment. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Placebo Effects in the Treatment of Noncognitive Symptoms of Alzheimer's Disease: Analysis of the CATIE-AD Data. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Effect of ninjin'yoeito, a Kampo (traditional Japanese) medicine, on cognitive impairment and depression in patients with Alzheimer's disease: 2 years of observation. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Understanding placebo responses in Alzheimer's disease clinical trials from the literature meta-data and CAMD database. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Current Alzheimer's disease clinical trials: methods and placebo outcomes. [2022]