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SNK01 for Alzheimer's Disease

Phase 1 & 2

Recruiting

Research Sponsored by NKGen Biotech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Female participants of childbearing potential must have a negative urine pregnancy test at Screening and Visit 1 before first administration of the study drug

Must not have

Substantial concomitant cerebrovascular disease defined as Fazekas Grade 3

Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Summary

This trial is testing a drug called SNK01 on people with moderate Alzheimer's Disease. The trial wants to know if SNK01 is safe and well-tolerated when given as an infusion every

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of SNK01 are not detailed here but typically could include reactions at the infusion site, general discomfort, or other symptoms related to immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am a woman who can have children and have a negative pregnancy test.

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I am between 40 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe brain blood vessel disease.

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I have not had cancer or cancer treatment in the last 5 years, except for basal cell carcinoma.

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I have not had a stroke, mini-stroke, or unexplained fainting in the past year.

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I have a lung condition that could lead to low oxygen levels.

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I do not have serious liver conditions like cirrhosis or active hepatitis.

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My liver tests are more than three times the normal limit.

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I do not have major stomach or intestine problems like recent bleeding or surgery.

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I have a significant allergy or a condition like Lupus or scleroderma.

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I do not have neurological or psychiatric conditions affecting my thinking.

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

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

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I do not have uncontrolled blood disorders like severe anemia.

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I do not have uncontrolled heart problems like heart failure or irregular heartbeat.

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I do not have severe heart issues like recent heart attacks or ongoing chest pain.

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I do not have HIV, hepatitis B, hepatitis C, or any other active infections.

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My kidney function is severely impaired.

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My major depression or anxiety has been stable for the last year.

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I have had seizures within the last three years.

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I do not have uncontrolled diabetes or overactive thyroid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose determination

Number of participants with dose-limiting toxicity

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

+5 more

Secondary study objectives

Changes in CSF biomarkers (pTau 181, Aβ42/40, GFAP, NfL)

Changes in plasma biomarkers (pTau 181, Aβ42/40, GFAP, NfL)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SNK01Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SNK01

2019

Completed Phase 1

~30

0 / 22Eligibility criteria met

Find a Location

Who is running the clinical trial?

NKGen Biotech, Inc.Lead Sponsor

6 Previous Clinical Trials

63 Total Patients Enrolled

~0 spots leftby Dec 2024

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