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New treatment option for Mild Cognitive Impairment
Official title Innate Immunity Stimulation Via TLR9 in Early AD
ClinicalTrials.gov ID: NCT05606341
What this study is testing
What is CpG1018?
CpG1018 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for mild cognitive impairment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85
You may be able to join if
- 65-85 years of age
- MCI due to AD or mild AD dementia per NIA-AA specified criteria published in 2018
- Montreal Cognitive Assessment (MoCA) score ≥17 AND;
- Positive Florbetaben PET amyloid scan, or other positive PET amyloid scan performed within one year of study enrollment
- Must be able to provide consent or assent (If applicable).
You likely can't join if
- History of psychiatric illness (e.g. hallucinations, major depression, suicidal ideation or delusions) that could interfere with completion of study...
- History of autoimmune disorders or antibody-mediated disease, severe asthma, or other serious infection or systemic illness, as determined by PI
- Use of corticosteroids or immunosuppressive drugs within 30 days of study entry
- History of splenectomy
- Renal impairment
- Use of chloroquine within 8 weeks of study entry
See the full eligibility criteria
- 65-85 years of age
- MCI due to AD or mild AD dementia per NIA-AA specified criteria published in 2018
- Montreal Cognitive Assessment (MoCA) score ≥17 AND;
- Positive Florbetaben PET amyloid scan, or other positive PET amyloid scan performed within one year of study enrollment
- Must be able to provide consent or assent (If applicable).
- Must be willing and able to participate in all study related procedures.
- 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...
- 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
- History of autoimmune disorders or antibody-mediated disease, severe asthma, or other serious infection or systemic illness, as determined by PI
- Use of corticosteroids or immunosuppressive drugs within 30 days of study entry
- History of splenectomy
- Renal impairment
- Use of chloroquine within 8 weeks of study entry
- Inability to undergo MRI imaging
- History of TIA, stroke or seizures within 12 months of screening
- Any neurological condition other than AD that could contribute to cognitive impairment (including related to possible "long COVID") as determined by PI
- Participation in any other current AD investigational treatment trial
- Current use of an anti-coagulant
- Current use of drugs that are major substrates of cytochrome P450 (CYP) enzyme 1A2
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.