Actively Recruiting
Phase 1 Clinical Trial of Innate Immunity Stimulation Via TLR9 in Early Alzheimer's Disease (AD)
Led by NYU Langone Health · Updated on 2026-01-07
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
A
Alzheimer's Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of CpG 1018, a drug that stimulates innate immunity via TLR9, in people aged 60 to 85 with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's disease dementia. This phase 1, double-blind, placebo-controlled study involves 39 participants divided into three dose groups to assess different dosing levels of CpG 1018. Participants receive three injections of CpG 1018 or placebo (sterile saline) at Day 1, Week 4, and Week 8. The dosing levels are 0.1 mg/kg, 0.25 mg/kg, and 0.5 mg/kg, administered via subcutaneous injection in the morning, followed by a one-hour observation period after each dose to monitor for injection site reactions or adverse effects. During the study, participants will undergo various assessments including cognitive tests like the ADAS-Cog-13 and MoCA, functional evaluations, and biomarker measurements in plasma and cerebrospinal fluid. MRI scans will monitor amyloid-related imaging abnormalities. Safety will be tracked through patient-reported adverse events and autoimmunity marker tests up to Week 18. The total participation period includes dosing and follow-up evaluations extending to Week 18.
CONDITIONS
Brief Title
Innate Immunity Stimulation Via TLR9 in Early AD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 65 to 85 years
- Diagnosed with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's dementia according to NIA-AA 2018 criteria
- Montreal Cognitive Assessment (MoCA) score of 17 or higher
- Positive Florbetaben PET amyloid scan or other positive PET amyloid scan within one year before enrollment
- Able to provide consent or assent if applicable
- Willing and able to participate in all study procedures
- Have a reliable study partner with sufficient contact who can provide cognitive and functional status information and accompany to visits or phone calls
You will not qualify if you...
- History of psychiatric illness such as hallucinations, major depression, suicidal thoughts, or delusions that interfere with study procedures
- History of autoimmune disorders, antibody-mediated diseases, severe asthma, or serious infections
- Use of corticosteroids or immunosuppressive drugs within 30 days before study entry
- History of splenectomy
- Renal impairment
- Use of chloroquine within 8 weeks before study entry
- Unable to undergo MRI imaging
- History of transient ischemic attack, stroke, or seizures within 12 months before screening
- Any neurological condition other than Alzheimer's disease that may affect cognition
- Participation in any other ongoing Alzheimer's investigational trial
- Current use of anticoagulant medications
- Current use of drugs that are major substrates of cytochrome P450 enzyme 1A2
- Recent exposure to COVID-19 infection or onset of related symptoms within 14 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive three subcutaneous injections of either CpG1018 at varying doses or placebo on Day 1, Week 4, and Week 8. Each injection is followed by a 1-hour observation period for injection site reactions and adverse events.
3 visits (in-person) at Day 1, Week 4, and Week 8
Duration - Up to 10 weeks after treatment
Participants are monitored for safety and cognitive outcomes up to Week 18 after the first injection.
Visits as scheduled up to Week 18 for assessments and monitoring
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
A
Anaztasia Ulysse
D
Dylan Nelson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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