Innate Immunity Stimulation Via TLR9 in Early AD

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Mild Cognitive Impairment
• Alzheimer Dementia

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

60 to 85 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

NYU Langone Health

Last updated on ClinicalTrials.gov

January 7, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites