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Innate Immunity Stimulation Via TLR9 in Early AD
Sponsor: NYU Langone Health
Summary
This single-center, double-blind, placebo-controlled study will recruit in total 39 participants with either Mild Cognitive Impairment due to Alzheimer's disease (MCI) or Mild Alzheimer's disease dementia (mild AD). There will be 3 Dose levels. An initial cohort of 13 subjects will be randomized to a Dose level 1 (0.1 mg/kg vs. placebo) lasting 8 weeks. An additional 13 subjects will be recruited and randomized into Dose level 2 (0.25 mg/kg vs. placebo) for 8 weeks and 13 subjects for the last Dose level 3 (0.5 mg/kg vs. placebo) for 8 weeks. The primary objective will be to assess safety and tolerability of CpG 1018.
Official title: Phase 1 Clinical Trial of Innate Immunity Stimulation Via TLR9 in Early Alzheimer's Disease (AD)
Key Details
Gender
All
Age Range
60 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2023-03-13
Completion Date
2026-11
Last Updated
2026-01-07
Healthy Volunteers
No
Interventions
CpG1018
0.1 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.
CpG1018
0.25 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.
CpG1018
0.5 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.
Placebo
Sterile saline injection supplied by the NYU Investigational Pharmacy.
Locations (1)
NYU Langone Health
New York, New York, United States