Innate Immunity Stimulation Via TLR9 in Early AD

Launched by NYU LANGONE HEALTH · Nov 1, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment that aims to boost the body's immune response in people with Mild Cognitive Impairment (MCI) or mild Alzheimer’s dementia. The study will involve 39 participants aged between 65 and 85 who have been diagnosed with these conditions. To be eligible, participants must have a certain score on a cognitive test and a positive brain scan showing amyloid, a protein linked to Alzheimer’s. Individuals with certain medical histories, including psychiatric issues or severe infections, will not be able to participate.

During the trial, participants will receive one of three different doses of the treatment or a placebo (a harmless substance with no active medication) over 8 weeks. The main goal is to check how safe the treatment is and how well people tolerate it. Participants can expect regular visits to the clinic where they will undergo assessments and have a study partner available to help provide information about their condition. This study is currently recruiting participants, and it’s an important step in finding new ways to help those affected by Alzheimer’s disease.

Gender

ALL

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