Innate Immunity Stimulation Via TLR9 in Early AD
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60-85
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CpG1018
- CpG1018
- CpG1018
- Placebo
Treatment groups
18 Participants
are divided into 4 treatment groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
Alzheimer's Association
Collaborator
Source ClinicalTrials.gov