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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
Summary
This trial tests the safety of CpG 1018 in people with early stages of Alzheimer's disease. Different doses are given to see how well it is tolerated. It works by stimulating the immune system, which may help manage Alzheimer's.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patient-Reported Adverse Events (AEs)
Amyloid
Amyloid
+3 moreSecondary study objectives
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 moreTrial 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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,741 Total Patients Enrolled
Alzheimer's AssociationOTHER
97 Previous Clinical Trials
42,624 Total Patients Enrolled
Arjun Masurkar, MDPrincipal InvestigatorNYU Langone Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids or immunosuppressants in the last 30 days.I am between 65 and 85 years old.I have kidney problems.I am currently taking medication that affects liver enzyme CYP1A2.I have had my spleen removed.I am currently taking blood thinners.I have not had a stroke, TIA, or seizures in the last year.I have been diagnosed with early-stage Alzheimer's disease.I have been exposed to COVID-19 or had symptoms that could be COVID-19 in the last 14 days.I have not taken chloroquine in the last 8 weeks.My cognitive function score is 17 or higher.I have someone who knows about my health and can come with me or be available by phone for my clinic visits.I do not have any brain conditions affecting my thinking, aside from Alzheimer's.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: CpG 1018 0.25 mg/kg
- Group 3: CpG 1018 0.1 mg/kg
- Group 4: CpG 1018 0.5 mg/kg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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