Menu
Recruiting NCT05606341

Innate Immunity Stimulation Via TLR9 in Early AD

Phase I Interventional Mild Cognitive Impairment Alzheimer Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CpG1018, CpG1018, CpG1018, Placebo.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment, Alzheimer Dementia. Basic parameters: 60 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 1 Clinical Trial of Innate Immunity Stimulation Via TLR9 in Early Alzheimer's Disease (AD)

Overview

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.

Interventions

  • Drug CpG1018
    0.1 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.
  • Drug CpG1018
    0.25 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.
  • Drug CpG1018
    0.5 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.
  • Drug Placebo
    Sterile saline injection supplied by the NYU Investigational Pharmacy.

Primary outcome measures

  • Number of Patient-Reported Adverse Events (AEs) [Time frame: Up to Week 18]
  • Percentage of Participants with Rheumatoid Factor (RF) Confirmed by Autoimmunity Marker Screening Test Result [Time frame: Up to Week 18]
  • Percentage of Participants with Antinuclear Antibody (ANA) Confirmed by Autoimmunity Marker Screening Test Result [Time frame: Up to Week 18]
  • Percentage of Participants with Antineutrophil Cytoplasmic Antibody (ANCA) Confirmed by Autoimmunity Marker Screening Test Result [Time frame: Up to Week 18]
  • Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI) [Time frame: Up to Week 14]
  • Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI) [Time frame: Up to Week 14]
Secondary outcome measures (9)
  • Change in AD Assessment Scale Cognitive Subscale (ADAS-Cog-13) Scores [Time frame: Baseline, Week 18]
  • Change in AD Cooperative Study-Activities of Daily Living Inventory, Mild Cognitive Impairment version (ADCS-ADL-MCI) Scores [Time frame: Baseline, Week 18]
  • Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores [Time frame: Baseline, Week 18]
  • Change in Global Clinical Dementia Rating (CDR-Global) [Time frame: Baseline, Week 18]
  • Change in Montreal Cognitive Assessment (MoCa) Score [Time frame: Baseline, Week 18]
  • Change in Plasma Amyloid Biomarker Concentration [Time frame: Baseline, Week 18]
  • Change in Cerebral Spinal Fluid (CSF) Amyloid Biomarker Concentration [Time frame: Baseline, Week 18]
  • Change in Plasma Tau Biomarker Concentration [Time frame: Baseline, Week 18]
  • Change in CSF Tau Biomarker Concentration [Time frame: Baseline, Week 18]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05606341 · 20-00267

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗