AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Individuals between the ages of 55-85;
✓. MCI or moderate dementia due to AD as defined by the 2011 NIA-AA Workgroup recommendations;
✓. MoCA ≥ 8 at screening;
✓. Global CDR between 0.5-2 (inclusive) at screening;
✓. Amyloid and/or tau biomarkers indicative of AD pathology;
✓. Education level, English language skills and literacy indicates subject will be able to complete all assessments;
✓. Has a study partner who, in the investigator's judgement, has frequent, direct contact with the participant at least several days a week, can accompany the participant to all visits, and is also able to provide information to study investigator/staff;
✓. Willing and able to complete all assessment and study procedures, including blood and lumbar punctures, and clinical assessments;
Exclusion criteria
✕. History of chronic infectious disease, such as HIV or untreated or active hepatitis;
✕. History of tuberculosis, positive interferon-gamma release assay (IGRA, also known as the QuantiFERON-TB test), including a test with a high reactivity to mycobacteria of non-tuberculosis variety;
✕. Prior BCG vaccination, positive T-spot tuberculosis test or a T-spot test showing significant Mycobacteria exposure;
What they're measuring
1
Blood Biomarkers of Pharmacodynamic Response- Cytokines
Timeframe: Baseline to Day 364
2
CSF Biomarkers of Pharmacodynamic Response- Cytokines
Timeframe: Baseline to Day 84
3
CSF Biomarkers of Pharmacodynamic Response- Cytokines
. A positive SARS-CoV-2 PCR result within 3 months of screening, or known close contact with a confirmed COVID-19 positive person or symptoms highly suspicious for COVID-19 (per CDC guidelines) within 1 month of screening, including fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea, and/or sore throat, based on clinician's judgment;
✕. History of treatment with metformin within the past one year;
✕. Treatment with other investigational agents which, at the discretion of the investigator, interfere with safety and/or study outcomes;
✕. Current treatment with immunosuppressants (calcineurin inhibitors, corticosteroids, or biological or cytotoxic immunosuppressants, or disease or condition likely to require high dose steroid or immunosuppressive therapy);
✕. Other conditions or treatments associated with increased risk of infections or treatment with immunosuppressive medications for any reason;
Cognitive Measures (RBANS)
Timeframe: Baseline to Day 364
10
Amyloid-β42/40 Average Difference in Blood
Timeframe: Baseline to Day 364
11
Amyloid-β42/40 Average Difference in CSF
Timeframe: Baseline to Day 364
12
Amyloid-β42/40 Average Difference in Blood - Baseline to Day 84
Timeframe: Baseline to Day 84
13
Amyloid-β42/40 Average Difference in CSF - Baseline to Day 84
Timeframe: Baseline to Day 84
14
Blood Biomarkers of Pharmacodynamic Response - Cytokines