RecruitingPhase 1NCT05606341

Innate Immunity Stimulation Via TLR9 in Early AD

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


Sponsor

NYU Langone Health

Enrollment

18 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a treatment that activates part of the immune system (via a receptor called TLR9) to see if it can slow down Alzheimer's disease in its early stages — either as mild cognitive impairment or mild dementia. **You may be eligible if...** - You are between 65 and 85 years old - You have been diagnosed with mild cognitive impairment or mild Alzheimer's dementia - Your Montreal Cognitive Assessment (MoCA) score is 17 or higher - You have had a positive amyloid PET scan (a brain scan showing Alzheimer's-related plaques) within the past year - You have a reliable study partner (family member, friend, or caregiver) who can accompany or contact you **You may NOT be eligible if...** - You have a history of psychiatric illness (e.g., hallucinations, major depression, suicidal thoughts) that could interfere with the study - You have autoimmune disorders, severe asthma, or major infections - You take corticosteroids or immune-suppressing drugs - You have had a stroke, TIA, or seizures in the past 12 months - You have another neurological condition contributing to memory problems - You are currently taking blood thinners or certain CYP1A2 enzyme-interacting drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCpG1018

0.1 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.

DRUGCpG1018

0.25 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.

DRUGCpG1018

0.5 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.

DRUGPlacebo

Sterile saline injection supplied by the NYU Investigational Pharmacy.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT05606341


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