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Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD)

Single Center, Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Subjects With Alzheimer's Disease (AD)

NCT04678453•NKGen Biotech, Inc.

View on ClinicalTrials.gov

Summary

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 the treatment of subjects with Alzheimer's disease.

Eligibility

Age

55 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and protocol. If the subject is incapable of giving or signing informed consent, the subject must have a legally authorized representative willing to consent on their behalf.
•Subject must be ≥ 55 to 85 years old at the time of consent.
•Magnetic resonance imaging (MRI) scans of the brain within the past six months reveal evidence and findings consistent with Alzheimer's disease, including hippocampal volume loss and/or overall cerebral atrophy (cerebral volume loss).
•Fluorodeoxyglucose-positron emission tomography (FDG-PET) scans of the brain within the past six months reveal evidence and findings consistent with mild cognitive impairment or Alzheimer's disease.
•Subject presenting, during evaluation by the study Investigator, to have spontaneous memory loss or presenting abnormal memory function in early screening.
•Subject must be in good health with adequate hearing and vision.
•Subject must have a reliable caregiver.
•Women of childbearing potential who are not abstinent and intend to be sexually active with a nonsterilized male partner must be willing to use an adequate method of contraception throughout the study and for one month following the last day of the last administration of final study drug dose. Acceptable methods include hormonal contraception (oral contraceptives \[taken 90 days prior to administration of study drug\], intrauterine devices (IUD), or double barrier methods (e.g., vaginal diaphragm/vaginal sponge plus condoms, or condom plus spermicidal jelly), sexual abstinence, or a vasectomized partner.

Exclusion Criteria

•Any medical or neurological conditions, other than Alzheimer's disease, that could contribute to the cause of cognitive impairment in the subject. Examples include, but are not limited to, frontotemporal dementia (FTD), Lewy body dementia, vascular dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, Huntington's disease, normal pressure hydrocephalus, seizure disorders or cerebral hypoxia, post-traumatic stress disorder (PTSD), or alcohol or medication use or abuse.
•Subject does not present with signs of mild cognitive impairment or Alzheimer's disease at screening, or during evaluation by the study Investigator.
•Subject presents with significant brain disease including hemorrhage or infarction.
•Subject has a history of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness during the past year.
•Subject has a history of schizophrenia, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, or any other clinically relevant psychiatric disease.
•Subject has a history of seizure episodes within the past three years.
•Subject has uncontrolled diabetes mellitus.
•Subject has a history of unstable angina, myocardial infarction, chronic heart failure, or clinically relevant conduction abnormalities within the year prior to screening.
•Subject suffers from renal or hepatic failure.
•Subject is infected with the human immunodeficiency virus (HIV), Hepatitis B (Hep B), Hepatitis C (Hep C), or any other infection or active systemic disease.
+5 more criteria

Locations (1)

Hospital Angeles Tijuana

Tijuana, Estado de Baja California, Mexico

Key Dates

Start Date

January 6, 2021

Primary Completion Date

August 16, 2023

Completion Date

January 31, 2024

Last Updated

March 1, 2024

Enrollment

ACTUAL participants

Conditions

Alzheimer DiseaseNeuro-Degenerative Disease

Interventions

SNK01

BIOLOGICAL

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

NCT07178210

Alzheimer DiseaseLymphatic Obstruction

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RECRUITINGEARLY_PHASE1

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

NCT04123314

Depressive SymptomsDepression+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD)

Inclusion Criteria

Exclusion Criteria

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

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