A Phase 1 interventional study of CpG1018 and CpG1018 in Mild Cognitive Impairment and Alzheimer Dementia, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by NYU Langone Health · Phase 1, Interventional, and Treatment
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 18 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: CpG1018
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.
Drug: CpG1018
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.
Drug: CpG1018
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.
Drug: Placebo
0.1 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.
0.25 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.
0.5 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.
Sterile saline injection supplied by the NYU Investigational Pharmacy.
Number of Patient-Reported Adverse Events (AEs)
AEs defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study.
Time frame: Up to Week 18
Percentage of Participants with Rheumatoid Factor (RF) Confirmed by Autoimmunity Marker Screening Test Result
Evaluation of RF in patient blood samples at Baseline, Day 56, Week 14 and Week 18.
Time frame: Up to Week 18
Percentage of Participants with Antinuclear Antibody (ANA) Confirmed by Autoimmunity Marker Screening Test Result
Evaluation of ANA in patient blood samples at Baseline, Day 56, Week 14 and Week 18.
Time frame: Up to Week 18
Percentage of Participants with Antineutrophil Cytoplasmic Antibody (ANCA) Confirmed by Autoimmunity Marker Screening Test Result
Evaluation of ANCA in patient blood samples at Baseline, Day 56, Week 14 and Week 18.
Time frame: Up to Week 18
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI)
Evaluation of ARIA-H at Baseline and Week 14 using 3T PET/MR Siemens Biograph system.
Time frame: Up to Week 14
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
Evaluation of ARIA-E at Baseline and Week 14 using 3T PET/MR Siemens Biograph system.
Time frame: Up to Week 14
Change in AD Assessment Scale Cognitive Subscale (ADAS-Cog-13) Scores
13-item self-assessment measuring levels of cognitive and non-cognitive dysfunctions from mild to severe. Total scores range from 0 to 85. Lower scores indicate greater cognitive performance. A decrease in scores indicates cognitive performance improved during the observational period.
Time frame: Baseline, Week 18
Change in AD Cooperative Study-Activities of Daily Living Inventory, Mild Cognitive Impairment version (ADCS-ADL-MCI) Scores
18-item questionnaire measuring a participant's basic and instrumental activities of daily living over the previous month. Total scores range from 0-53, where higher scores indicate greater competence in performing activities. An increase in scores indicates competence increased during the observational period.
Time frame: Baseline, Week 18
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). A decrease in scores indicates suicidal ideation and behavior decreased during the observational period.
Time frame: Baseline, Week 18
Change in Global Clinical Dementia Rating (CDR-Global)
5-point questionnaire assessing six domains of cognitive and functional performance applicable to Alzheimer's disease and related dementias: Memory, Orientation; Judgement \& Problem Solving; Community Affairs; Home \& Hobbies; and Personal Care. Higher scores indicate greater severity of dementia: 0= Normal, 0.5=very mild dementia, 1=mild dementia, 2=moderate dementia, 3=severe dementia.
Time frame: Baseline, Week 18
Change in Montreal Cognitive Assessment (MoCa) Score
30-item assessment of global cognitive function. Total scores range from 0 to 30, with higher scores indicating greater cognitive function. Scores of 26 and higher are consider to be normal. An increase in scores indicates cognitive function increased during the observational period.
Time frame: Baseline, Week 18
Change in Plasma Amyloid Biomarker Concentration
Amyloid biomarker concentration detected via plasma analysis.
Time frame: Baseline, Week 18
Change in Cerebral Spinal Fluid (CSF) Amyloid Biomarker Concentration
Amyloid biomarker concentration detected via CSF analysis.
Time frame: Baseline, Week 18
Change in Plasma Tau Biomarker Concentration
Tau biomarker concentration detected via plasma analysis.
Time frame: Baseline, Week 18
Change in CSF Tau Biomarker Concentration
Tau biomarker concentration detected via CSF analysis.
Time frame: Baseline, Week 18
Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Alok.Vedvyas@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
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