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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNK01 | Experimental | SNK01 will be administered as an IV infusion Q3W for up to 1 year. |
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| Placebo | Placebo Comparator | Placebo will be administered as an IV infusion Q3W for up to 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNK01 | Biological | SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose-limiting toxicity | DLTs will be assessed by the review of labs, PE and AEs | 3 weeks |
| Maximum tolerated dose determination | Determine the maximum tolerated dose based on the evaluation of the number of participants who experience a DLT which will then determine the RP2D. | 3 weeks |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Evaluate the safety and tolerability of SNK01 assessed by labs, PE and AEs | 1 Year |
| Preliminary efficacy in cognitive assessment scores of CDR-SB | Measure changes in cognitive assessment of CDR-SB from baseline | 1 Year |
| Preliminary efficacy in cognitive assessment scores of MMSE | Measure changes in cognitive assessment of MMSE from baseline | 1 Year |
| Preliminary efficacy in cognitive assessment scores of NPI | Measure changes in cognitive assessment of NPI from baseline | 1 Year |
| Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe | Measure changes in cognitive assessment of ADCS-ADL-Severe from baseline | 1 Year |
| Preliminary efficacy in cognitive assessment scores of ADAS-Cog |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CSF biomarkers (pTau 181, Aβ42/40, GFAP, NfL) | Measure changes in CSF biomarkers as changed from baseline | 1 Year |
| Changes in plasma biomarkers (pTau 181, Aβ42/40, GFAP, NfL) | Measure changes in Plasma biomarkers as changed from baseline |
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Inclusion Criteria:
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. Informed consent for participants or their legally authorized representative and caregivers will be obtained before any trial-related activity. (Trial-related activities are any procedure that would not be performed during normal treatment of the participant).
Participants must have a reliable study partner/caregiver (per investigator judgement for instance a family member, partner etc., guardian (must be always the same person)) who is in close contact with the patient, available on call and who is able to contribute to the assessment of the ratings of the functional endpoints at specific study visits. This person will be able to communicate in the language in which the participant is being assessed and should also serve as a backup contact for the study site. The study partner/caregiver must sign a separate informed consent form which describes their contributions during the study.
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.
Age 40 to 85 years old.
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.
Female participants of childbearing potential must have a negative urine pregnancy test at Screening and Visit 1 before first administration of the study drug. Females of childbearing potential are defined as those who are not surgically sterile or who are not post-menopausal (i.e.: no menses for at least 1 year). Male and female participants of reproductive potential must also agree to abstinence or use acceptable form(s) of effective contraception during the study and for 30 days after the final dose of the study drug. Acceptable methods of contraception include the following:
Positive evidence for a diagnosis of AD via amyloid positron emission tomography (Amyloid PET) of the brain within the past six months.
CDR-SB score of ≥ 9.5 and <16.0.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 949-396-6830 | trials@nkgenbiotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Research Specialists, LLC | Recruiting | Glendale | California | 91206 | United States |
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| Placebo | Other | Sodium Lactate Hartmann's Solution |
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Measure changes in cognitive assessment of ADAS-Cog from baseline |
| 1 Year |
| 1 Year |
| Syrentis Clinical Research | Recruiting | Santa Ana | California | 92705 | United States |
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| Valiance Clinical Research | Withdrawn | Tarzana | California | 91356 | United States |
| K2 Medical Research | Recruiting | Maitland | Florida | 32751 | United States |
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| AdventHealth Research Institute | Recruiting | Orlando | Florida | 32804 | United States |
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| Rutgers Health | Recruiting | Newark | New Jersey | 07107 | United States |
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| Alzheimer's Disease Research Center | Recruiting | Albany | New York | 12208 | United States |
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| Ottawa Memory Clinic | Withdrawn | Ottawa | Ontario | K1Z 1G3 | Canada |