SNK01 for Alzheimer's Disease

Recruiting at 4 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called SNK01 for individuals with moderate Alzheimer's Disease. The main goals are to determine the safety of SNK01 and its potential to improve memory and thinking skills. Participants will receive either SNK01 (an experimental treatment) or a placebo through an IV every three weeks for up to a year. Those diagnosed with Alzheimer's and who have had a brain scan showing signs of the disease might be suitable for this study. As a Phase 1, Phase 2 trial, this study aims to understand how SNK01 works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that SNK01 is well tolerated by patients with Alzheimer's Disease. Research indicates that SNK01 not only positively affects the disease but also benefits certain brain proteins and inflammation markers. Participants reported no major side effects, suggesting SNK01 may be safe for humans. Additionally, 90% of patients demonstrated stable or improved thinking and memory skills after 11 weeks of treatment. This provides promising evidence that SNK01 could be a safe option for those considering participation in this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SNK01 is unique because it offers a fresh approach to treating Alzheimer's Disease. Unlike traditional treatments that mainly aim to manage symptoms, SNK01 is delivered as an intravenous infusion and is being studied for its potential to alter the disease's progression. Researchers are excited about its novel mechanism, which could provide new hope in slowing down or modifying the underlying pathology of Alzheimer's, rather than just addressing cognitive symptoms. This makes SNK01 a promising candidate to potentially improve the quality of life for those affected by this challenging condition.

What evidence suggests that SNK01 might be an effective treatment for Alzheimer's Disease?

In this trial, participants will receive either SNK01 or a placebo. A previous study showed that patients with Alzheimer's Disease tolerated SNK01 well and it showed signs of effectiveness. Research has indicated that SNK01 can positively affect certain protein levels in the brain and reduce brain inflammation, both crucial in Alzheimer's. These early findings suggest that SNK01 might help improve thinking and memory in patients. While researchers are still gathering complete results, these signs offer hope for its effectiveness in treating Alzheimer's symptoms. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. nkgenbiotech.com nkgenbiotech.com/nkgen-biotechs-snk01-nk-cell-therapy-cleared-to-start-phase-2-clinical-trial-in-alzheimers-disease/

NKGen Biotech's SNK01 NK Cell Therapy Cleared to Start ... Company advances SNK01 into Phase 2 in moderate Alzheimer's disease; first patient enrolled in Phase 2 expected in Q2 2024.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06189963

NCT06189963 | Clinical Study of SNK01 in Participants ... 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:.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39939891/

Treatment of Alzheimer's Disease subjects with expanded ... SNK01 was well tolerated and appeared to have clinical activity in AD while also having beneficial effects on cerebrospinal fluid protein and neuroinflammatory ...

4. nkgenbiotech.com nkgenbiotech.com/clinical-trials/

Clinical Trials NKGen Biotech is currently conducting clinical trials to evaluate the potential benefits of our SNK therapy with the goal of improving outcomes for patients.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04678453

Safety of SNK01 in Subjects With Alzheimer's Disease ... The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent, for ...

6. nkgenbiotech.com nkgenbiotech.com/nkgen-biotech-presents-new-positive-snk01-biomarker-data-at-the-2024-alzheimers-association-international-conference/

NKGen Biotech Presents New Positive SNK01 Biomarker ... In addition, 90% of patients (median MMSE score of 14 at baseline) showed stable or improved cognitive function at 11 weeks using the ADCOMS ...