Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease

Conditions

• Moderate Alzheimer Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• SNK01 — BIOLOGICAL
  SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug
• Placebo — OTHER
  Sodium Lactate Hartmann's Solution

Study Details

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

Key Dates

Start date

Nov 21, 2023

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: SNK01
  SNK01 will be administered as an IV infusion Q3W for up to 1 year.
• Placebo Comparator: Placebo
  Placebo will be administered as an IV infusion Q3W for up to 1 year.

Primary Outcome Measure

Number of participants with dose-limiting toxicity [ Time Frame: 3 weeks ]

Central Contacts

• Study Director
  949-396-6830
  [email protected]

Locations (7)

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