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RECRUITING
NCT05606341
PHASE1

Innate Immunity Stimulation Via TLR9 in Early AD

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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

DRUG

CpG1018

0.1 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.

DRUG

CpG1018

0.25 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.

DRUG

CpG1018

0.5 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.

DRUG

Placebo

Sterile saline injection supplied by the NYU Investigational Pharmacy.

Locations (1)

NYU Langone Health

New York, New York, United States