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Immunostimulant

TLR9 Stimulation for Alzheimer's Disease

Phase 1
Recruiting
Led By Arjun Masurkar, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 18
Awards & highlights

Study Summary

This trial tests a new drug to assess safety and tolerability for those with Mild Cognitive Impairment or Mild Alzheimer's Disease. 39 people will be recruited and randomized into 3 dose levels.

Who is the study for?
This trial is for people aged 65-85 with Mild Cognitive Impairment or mild Alzheimer's dementia, who can consent to participate and have a study partner. They must score ≥17 on the MoCA test and show positive amyloid scans. Excluded are those with certain psychiatric illnesses, history of severe immune-related diseases, recent use of anticoagulants or immunosuppressives, inability to undergo MRI, renal impairment, recent strokes or seizures.Check my eligibility
What is being tested?
The study tests CpG1018's safety at three dose levels against placebo in participants with early-stage Alzheimer's over 8 weeks per group. It aims to stimulate innate immunity via TLR9 as a potential treatment pathway for cognitive impairments associated with Alzheimer’s disease.See study design
What are the potential side effects?
While specific side effects aren't listed here, the primary goal is assessing the safety and tolerability of CpG1018 which suggests monitoring for any adverse reactions related to immune stimulation such as inflammation or allergic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patient-Reported Adverse Events (AEs)
Amyloid
Amyloid
+3 more
Secondary outcome measures
Change in AD Assessment Scale Cognitive Subscale (ADAS-Cog-13) Scores
Change in AD Cooperative Study-Activities of Daily Living Inventory, Mild Cognitive Impairment version (ADCS-ADL-MCI) Scores
Change in CSF Tau Biomarker Concentration
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: CpG 1018 0.5 mg/kgExperimental Treatment1 Intervention
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.
Group II: CpG 1018 0.25 mg/kgExperimental Treatment1 Intervention
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.
Group III: CpG 1018 0.1 mg/kgExperimental Treatment1 Intervention
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.
Group IV: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,726 Total Patients Enrolled
Alzheimer's AssociationOTHER
89 Previous Clinical Trials
40,748 Total Patients Enrolled
Arjun Masurkar, MDPrincipal InvestigatorNYU Langone Medical Center

Media Library

CpG1018 (Immunostimulant) Clinical Trial Eligibility Overview. Trial Name: NCT05606341 — Phase 1
Alzheimer's Dementia Research Study Groups: Placebo, CpG 1018 0.25 mg/kg, CpG 1018 0.1 mg/kg, CpG 1018 0.5 mg/kg
Alzheimer's Dementia Clinical Trial 2023: CpG1018 Highlights & Side Effects. Trial Name: NCT05606341 — Phase 1
CpG1018 (Immunostimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05606341 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for prospective participants of this research project?

"Patients between the ages of 60 and 85 are eligible to participate in this trial."

Answered by AI

Is the administration of CpG 1018 0.1 mg/kg to patients safe?

"Our personnel at Power judged the security of CpG 1018 0.1 mg/kg to be 1, as there is not much information concerning its effectiveness and safety due to it being a Phase 1 trial."

Answered by AI

Does my medical profile meet the prerequisites for participating in this trial?

"Patient eligibility for this trial requires a diagnosis of alzheimer's dementia and an age between 60 and 85. Approximately 39 individuals are required to complete the study."

Answered by AI

How many test subjects are involved in this research endeavor?

"Affirmative. The information found on clinicaltrials.gov reveals that this medical research is currently seeking participants, with the trial first appearing on March 13th 2023 and most recently modified April 10th 2023. This study requires 39 patients from one centre to take part in it."

Answered by AI

Are there any remaining vacancies in this research project?

"Confirmed, this trial is recruiting patients. Clinicaltrials.gov reveals that the study was posted on March 13th 2023 and recently updated on April 10th of the same year."

Answered by AI

What overarching goals are being sought through the execution of this research?

"The main outcome of this study, to be assessed until Week 18, is the Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin (ARIA-H) as verified by Magnetic Resonance Imaging (MRI). Other secondary objectives include evaluating changes in Global Clinical Dementia Rating (CDR-Global), Montreal Cognitive Assessment (MoCa), and Plasma Amyloid Biomarker Concentration."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Innate Immunity Stimulation Via TLR9 in Early AD
2023. "Innate Immunity Stimulation Via TLR9 in Early AD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05606341.
All > Alzheimers Disease New York
~9 spots leftby Nov 2025
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