Stimulating the immune system to treat early Alzheimer's disease

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

This study is testing a new treatment to see if it can safely boost the immune system in older adults with early Alzheimer's disease or mild cognitive impairment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05606341 on ClinicalTrials.gov

What this trial studies

This interventional study aims to evaluate the safety and tolerability of CpG 1018 in older adults with Mild Cognitive Impairment or mild Alzheimer's disease dementia. A total of 39 participants will be randomized into three different dose levels of the treatment or placebo, with each dose administered over an 8-week period. The study is designed as a single-center, double-blind, placebo-controlled trial to ensure unbiased results and participant safety.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 65-85 with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's dementia.

Not a fit: Patients with a history of psychiatric illness or autoimmune disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with early Alzheimer's disease, potentially slowing cognitive decline.

How similar studies have performed: While this approach is novel, similar studies targeting immune modulation in Alzheimer's have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. 65-85 years of age
2. MCI due to AD or mild AD dementia per NIA-AA specified criteria published in 2018
3. Montreal Cognitive Assessment (MoCA) score ≥17 AND;
4. Positive Florbetaben PET amyloid scan, or other positive PET amyloid scan performed within one year of study enrollment
5. Must be able to provide consent or assent (If applicable).
6. Must be willing and able to participate in all study related procedures.
7. Must have a reliable study partner to provide information on the subject's cognitive and functional status. Study partner must have sufficient contact with the subject, as determined by the PI, and be available to accompany the subject to clinic visits or by phone.

Exclusion Criteria:

1. History of psychiatric illness (e.g. hallucinations, major depression, suicidal ideation or delusions) that could interfere with completion of study related procedures as determined by PI
2. History of autoimmune disorders or antibody-mediated disease, severe asthma, or other serious infection or systemic illness, as determined by PI
3. Use of corticosteroids or immunosuppressive drugs within 30 days of study entry
4. History of splenectomy
5. Renal impairment
6. Use of chloroquine within 8 weeks of study entry
7. Inability to undergo MRI imaging
8. History of TIA, stroke or seizures within 12 months of screening
9. Any neurological condition other than AD that could contribute to cognitive impairment (including related to possible "long COVID") as determined by PI
10. Participation in any other current AD investigational interventional trial
11. Current use of an anti-coagulant
12. Current use of drugs that are major substrates of cytochrome P450 (CYP) enzyme 1A2
13. Recent exposure to COVID-19 infection within 14 days or recent onset of symptoms within 14 days that may be related to COVID-19 infection

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Arjun Masurkar, MD — NYU Langone Medical Center
• Study coordinator: Anaztasia Ulysse

Conditions Mild Cognitive Impairment; Alzheimer Dementia