NCT05606341RecruitingPhase 1
Innate Immunity Stimulation Via TLR9 in Early AD
Phase 1 Clinical Trial of Innate Immunity Stimulation Via TLR9 in Early Alzheimer's Disease (AD)
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 1 Nov 2022
- Start date
- 13 Mar 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- NYU Langone Health
- Diseases
- Alzheimer disease
- NCT number
- NCT05606341
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 13 Mar 2023 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of corticosteroids or immunosuppressive drugs within 30 days of study entry
- Current use of drugs that are major substrates of cytochrome P450 (CYP) enzyme 1A2
Other illness
- History of psychiatric illness (e.g. hallucinations, major depression, suicidal ideation or delusions) that could interfere with completion of study related procedures as determined by PI
- History of autoimmune disorders or antibody-mediated disease, severe asthma, or other serious infection or systemic illness, as determined by PI
- History of splenectomy
- Renal impairment
- History of TIA, stroke or seizures within 12 months of screening
- Any neurological condition other than AD that could contribute to cognitive impairment (including related to possible "long COVID") as determined by PI
- Recent exposure to COVID-19 infection within 14 days or recent onset of symptoms within 14 days that may be related to COVID-19 infection
Other
- Use of chloroquine within 8 weeks of study entry
- Inability to undergo MRI imaging
- Participation in any other current AD investigational interventional trial
- Current use of an anti-coagulant
Who the study is looking for
- 65-85 years of age
- MCI due to AD or mild AD dementia per NIA-AA specified criteria published in 2018
- Montreal Cognitive Assessment (MoCA) score ≥17 AND;
- Positive Florbetaben PET amyloid scan, or other positive PET amyloid scan performed within one year of study enrollment
- Must be able to provide consent or assent (If applicable).
- Must be willing and able to participate in all study related procedures.
- Must have a reliable study partner to provide information on the subject's cognitive and functional status. Study partner must have sufficient contact with the subject, as determined by the PI, and be available to accompany the subject to clinic visits or by phone.
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.