Innate Immunity Stimulation Via TLR9 in Early AD
Mild Cognitive Impairment, Alzheimer Dementia
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Use of corticosteroids or immunosuppressive drugs within 30 days of study entry History of splenectomy Renal impairment Use of chloroquine within 8 weeks of study entry Inability to undergo MRI imaging 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 Participation in any other current AD investigational interventional trial Current use of an anti-coagulant Current use of drugs that are major substrates of cytochrome P450 (CYP) enzyme 1A2 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
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
CpG 1018 0.1 mg/kg
CpG 1018 0.25 mg/kg
CpG 1018 0.5 mg/kg
Placebo
3 injections at Day 1, Week 4, and Week 8. Treatment administered as morning injection of dose 0.1mg/kg, followed by 1-hour post-dose observation period to check for injection site reaction and/or adverse reactions.
3 injections at Day 1, Week 4, and Week 8. Treatment administered as morning injection of dose 0.25 mg/kg, followed by 1-hour post-dose observation period to check for injection site reaction and/or adverse reactions.
3 injections at Day 1, Week 4, and Week 8. Treatment administered as morning injection of dose 0.5 mg/kg, followed by 1-hour post-dose observation period to check for injection site reaction and/or adverse reactions.
3 injections of sterile saline at Day 1, Week 4, and Week 8, followed by 1-hour post-dose observation period to check for injection site reaction and/or adverse reactions.