SNK01 for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: NKGen Biotech, Inc.

Must not be taking: Anticoagulants, AD medications

Disqualifiers: Cerebrovascular disease, Cancer, Cardiovascular, others

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}

Research Team

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.

Trial 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 (Other)
• SNK01 (Other)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Syrentis Clinical Research Santa Ana, CA

Valiance Clinical Research Tarzana, CA

Behavioral Research Specialists, LLC Glendale, CA

Who Is Running the Clinical Trial?

NKGen Biotech, Inc.

Lead Sponsor

Trials

7

Patients Recruited

100+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]