Biological/Vaccine: Bacillus Calmette-Guerin (BCG) for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Alzheimer's Clinical and Translational Research Unit, Charlestown, MA
Alzheimer Disease+5 More
Biological/Vaccine: Bacillus Calmette-Guerin (BCG) - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A Trial to Evaluate the Effects of BCG in Adults With MCI and Mild-to-Moderate AD

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Eligible Conditions

  • Alzheimer Disease
  • Moderate Dementia
  • Mild Cognitive Impairment (MCI)
  • Mild Dementia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Biological/Vaccine: Bacillus Calmette-Guerin (BCG) will improve 5 primary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Day 84.

Day 364
CSF biomarkers of pharmacodynamic response- cytokines
Cognitive Measures (RBANS)
Day 84
Blood biomarkers of AD pathology-ATN
Blood biomarkers of pharmacodynamic response- cytokines
CSF biomarkers of AD pathology-ATN

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

BCG
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Biological/Vaccine: Bacillus Calmette-Guerin (BCG) is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

BCG
Biological
Active BCG immunization
Placebo
Other
Placebo immunization

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 364
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 364 for reporting.

Closest Location

Alzheimer's Clinical and Translational Research Unit - Charlestown, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals between the ages of 55-85;
You have MCI or moderate dementia due to AD as defined by the 2011 NIA-AA Workgroup recommendations. show original
You have a MoCA score of at least 8 at screening. show original
CDR between 0.5 and 2.0 at screening. show original
You have a biomarker indicative of Alzheimer's disease pathology. show original
Subject will be able to complete all assessments. show original
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;
If on cholinesterase inhibitor and/or memantine, doses are stable for 3 months prior to baseline;
You have not had a positive test for HIV antibody or tuberculosis (QuantiFERON) in the past 12 months. show original

Patient Q&A Section

What causes dementia?

"Brain aging appears to be a common cause of dementia. While risk factors are established, the causes of dementia are not well understood, and it is likely a combination of both genetics and lifestyle. Current evidence suggests that changes in brain structure play a central role in the development of dementia. Dementia can be prevented and reduced by exercising and managing risk factors for aging." - Anonymous Online Contributor

Unverified Answer

What are common treatments for dementia?

"Dementia has a strong family component. There are no cures for dementia. However, treatments can be helpful in easing the burden for patients, their caretakers and society at large. There are many different types of interventions targeted at people with dementia, as well as dementia-specific care, for which care-giving organisations are particularly well placed to provide. These interventions, which have been shown to be equally effective across the lifespan, may include personal care, care-giving support, rehabilitation or behavioural interventions, educational activities, and emotional support for families. The scope of interventions in dementia may be too narrow for clinicians to take up all aspects of people‘s needs." - Anonymous Online Contributor

Unverified Answer

How many people get dementia a year in the United States?

"In a country with high rates of older adults with dementia, about 75,000 are diagnosed with dementia a year. Older adults with dementia are more likely to be white, male, to be uninsured, or to have low educational levels. In addition, they are more likely to have poorer health or incomes, and are more likely to face multiple other health problems, than those without dementia." - Anonymous Online Contributor

Unverified Answer

What are the signs of dementia?

"Neurological signs are usually the presenting feature of dementia. Cognitive symptoms are frequently not mentioned by non-medical caregivers. This could potentially explain why dementia is rarely recognized as a reason for older people to attend clinic. Neurologic signs are more frequent and severe in people with mild cognitive impairment." - Anonymous Online Contributor

Unverified Answer

What is dementia?

"Dementia is a neurodegenerative condition characterized by a variety of cognitive and behavioural changes. Dementia is a major health problem that affects the daily life of patients and their carers, often in an irreversible, progressive manner. It is the third most common cause of disability and is frequently complicated by co-existing chronic conditions such as depression, anxiety and difficulty adjusting to the changes in role expectations. The prevalence of dementia in New Zealand is estimated at 1.4% - 3.4% of the total population depending on the age group studied and the method of measuring prevalence." - Anonymous Online Contributor

Unverified Answer

Can dementia be cured?

"We can say that most dementias aren't caused by viruses in the brain as some people believe, but from the interaction of our brain anatomy, chemical imbalance, and genetics.(Brain Science Foundation) With medication, lifestyle, and diet, some people with dementia can regain the quality of life they enjoyed before their dementia" - Anonymous Online Contributor

Unverified Answer

What are the latest developments in biological/vaccine: bacillus calmette-guerin (bcg) for therapeutic use?

"Currently BCG is regarded as an immunostimulant that is not indicated for 'therapeutic use' in older children who experience an unexplained febrile illness or as a prophylactically measure for individuals who are at risk for immunosuppression. These children receive BCG vaccination as a routine preventive measure. The rationale for vaccinating BCG-naïve children is to reduce morbidity and mortality from a mycobacterial infection. Since BCG is now widely available, it can be injected as a 'therapeutic' measure. A variety of studies have demonstrated that BCG vaccine is very effective at clearing persistent bacilli which can persist after vaccination in the bloodstream." - Anonymous Online Contributor

Unverified Answer

Has biological/vaccine: bacillus calmette-guerin (bcg) proven to be more effective than a placebo?

"BCG injection significantly reduced the risk of Meningitis. The study suggests that BCG is effective and safe in preventing and treating meningitis caused by Meningitic WN." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets dementia?

"There is an expectation that older people with dementia will be more likely to be female. The average age at onset at about 65 years old shows that there used to be an expectation that males would be more affected. Over the last decade many studies have looked at this, but their results are mixed. However, studies done in 2003 showed that the prevalence of dementia was higher in females than in males.\n" - Anonymous Online Contributor

Unverified Answer

What is biological/vaccine: bacillus calmette-guerin (bcg)?

"Vaccines such as bacillus calmette-guerin are well tolerated by most adults. Vaccinations could prevent, or at least delay, the onset of Alzheimer disease. The evidence is inconclusive regarding whether the vaccine is harmful or beneficial to patients with the disease. There is no convincing evidence that vaccinations prevent dementia. There is, however, some evidence that certain types of vaccinations could reduce the risk of developing some aspects of dementia (such as vascular dementia), but this needs further study. Vaccinations against infectious diseases that are still in the developmental stage (such as measles, typhoid fever (paint-thinner), influenza and pneumococcal pneumonia) do not appear to increase the risk of cognitive dysfunction." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for dementia?

"There does not appear to be evidence that we can apply the principles of the medical community to support clinical trials. Those interested in clinical trials in dementias would be well-served if they followed a set of rules to maximize their chances of achieving their outcome. Clinically we have to accept that we are a medical community. This is a challenge that will be pursued through research, and through education and training. These are the ways that we hope to bring these principles to bear." - Anonymous Online Contributor

Unverified Answer

What is the latest research for dementia?

"There's still a lot of things to do with dementia research but recent advances have brought about new discoveries for treatment, prevention and the future of dementia.\n\nWhat is new in the literature about dementia, that will modify the care of patients with dementia?\n- Recent advances in the treatment of dementia have focused on acetylcholinesterase inhibitors. This type of medication helps treat cognitive dysfunction in dementia. Some evidence suggests niacin may be effective in treating Alzheimer’s disease.\n- While vitamin B improves memory and thought function in people with dementia, it's unclear if it is more effective than placebo for people with mild or moderate dementia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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