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

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

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

+3 more

Secondary 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 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.

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