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SNK01 for Alzheimer's

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

NKGen Biotech, Inc.Lead Sponsor
6 Previous Clinical Trials
63 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for individuals interested in participating in this research project?

"To be eligible for enrollment in this clinical trial, individuals must have a diagnosis of Alzheimer's disease and fall within the age range of 40 to 85 years old. The study has capacity for approximately 36 participants."

Answered by AI

Is there an age restriction for potential participants, specifically targeting individuals above the age of 55?

"To be eligible for this clinical trial, patients must fall between the ages of 40 and 85. It's worth noting that there are 13 studies specifically designed for individuals under the age of 18, as well as an additional 525 studies targeting patients over the age of 65."

Answered by AI

What is the current number of participants involved in this clinical study?

"Indeed, the information found on clinicaltrials.gov indicates that this trial is currently seeking individuals to participate. The initial posting of the study was on November 21st, 2023, and it was last updated on January 3rd, 2024. A total of 36 patients are being sought from a single location."

Answered by AI

Are researchers actively seeking participants for this study at the moment?

"Indeed, as per the information available on clinicaltrials.gov, this particular clinical trial is actively seeking participants. The initial posting of the study took place on November 21st, 2023 and it was last updated on January 3rd, 2024. The trial aims to enroll a total of 36 patients from one designated location."

Answered by AI

Who else is applying?

What site did they apply to?
Behavioral Research Specialists, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease
2023. "Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06189963.
All > Alzheimers Disease Anaheim
~21 spots leftby Dec 2024
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