Actively Recruiting
Innate Immunity Stimulation Via TLR9 in Early AD
Led by NYU Langone Health · Updated on 2026-01-07
18
Participants Needed
1
Research Sites
189 weeks
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
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.
CONDITIONS
Official Title
Innate Immunity Stimulation Via TLR9 in Early AD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 65 and 85 years
- Diagnosis of Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's dementia according to NIA-AA 2018 criteria
- Montreal Cognitive Assessment (MoCA) score 17 or higher
- Positive Florbetaben PET amyloid scan or other positive PET amyloid scan within one year of enrollment
- Ability to provide consent or assent if applicable
- Willingness and ability to participate in all study procedures
- Availability of a reliable study partner familiar with the participant's cognitive and functional status
You will not qualify if you...
- History of psychiatric illness that could interfere with study participation (e.g., hallucinations, major depression, suicidal thoughts, delusions)
- History of autoimmune disorders, antibody-mediated disease, severe asthma, or serious infection or systemic illness
- 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
- Inability to undergo MRI imaging
- History of transient ischemic attack (TIA), stroke, or seizures within 12 months before screening
- Any neurological condition other than Alzheimer's disease that could cause cognitive impairment
- Participation in any other current investigational trial for Alzheimer's disease
- 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 related symptoms within 14 days before study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
A
Anaztasia Ulysse
CONTACT
D
Dylan Nelson
CONTACT
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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