A Trial to Evaluate the Effects of BCG in Adults With MCI and Mild-to-Moderate AD (NCT05004688) | Clinical Trial Compass
CompletedPhase 2
A Trial to Evaluate the Effects of BCG in Adults With MCI and Mild-to-Moderate AD
United States15 participantsStarted 2022-03-25
Plain-language summary
A study of the effects of Bacillus Calmette-Guérin (BCG) immunization on cerebrospinal fluid and blood-based biomarkers in older with mild cognitive impairment and mild-to-moderate to Alzheimer's disease.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. Prior BCG vaccination, positive T-spot tuberculosis test or a T-spot test showing significant Mycobacteria exposure;
. 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;
Timeframe: Baseline to Day 84
9
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