Alzheimer Disease, Late Onset Clinical Trial
Official title:
Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?
The goal of this clinical trial is to test whether vaccination with the BCG vaccine may improve the blood level of a biomarker of Alzheimer's disease (AD) in participants who are cognitively- and functionally- intact elderly (70-80 years old) participants, who display pathologically high levels of the blood biomarker. The main questions it aims to answer are: - Does BCG vaccination lower the plasma level of phosphorylated Tau protein (p-tau181). - Do vaccinated participants remains stable cognitively. Participants will be asked to: - Undergo cognitive and behavioral evaluation. - Receive 3 BCG vaccinations over the course of 1 year. - Perform blood tests on several occasions. All participants will be treated and followed.
Brain accumulation of insoluble Beta-Amyloid and of hyperphosphorylated tau protein -rich neurofibrillary tangles in Alzheimer's disease (AD), accompanied by oxidative stress and sustained inflammation develops approximately 20 years before appearance of symptomatic dementia. These years should be regarded as an incubation period of a deadly condition during which early therapeutic intervention may increase the likelihood of obtaining a significant disease modifying effect. Early diagnosis at the pre-symptomatic stage has been hindered by the lack of reliable, inexpensive and non-invasive biomarkers of disease. Recent developments have enabled the measurement of plasma p-tau181 level, which has almost 90% sensitivity and specificity for diagnosing AD. As these biomarkers identify AD pathology prior to clinical presentation, they enable identifying pre-symptomatic patients, with potential of early intervention. P-tau181, neurofilament light (NfL) and GFAP biomarkers may also serve as outcome measures, corresponding to the severity of active neurodegenerative disease in AD. The investigators propose to select 60 individuals who are at high risk for developing AD dementia for a single-arm prospective intervention study, by screening cognitively- and functionally-intact elderly population with non-genetic AD risk factors (around 250 individuals, 70-79 years old) for high plasma p-tau181 level. The current lack of any disease modifying drug in AD urged them to test if BCG vaccination can prevent, or at least postpone AD. The rationale is based on multiple scientific observations and on the dramatic reduction (by 30-50%) in development of dementia in elderly patients with bladder cancer who were treated with multiple intra-vesicular BCG instillations. Accumulating data argue for the critical role of the immune system in the course of AD. BCG through its immune-modulation properties (Tregs, pDCs and IL10 enhancement, M1:M2 macrophage balance) may mitigate the inflammatory process component of AD and therefore may prevent or delay full blown AD. In this single arm prospective study, three BCG vaccinations will be provided to the 60 recruited participants over one year. At recruitment and at three times during the two years' study period, they will be tested for plasma p-tau181 level, and for plasma Nfl and/or GFAP using SIMOA technology. The baseline p-tau181 will serve as a reference value for monitoring individual response to the BCG vaccinations during the study, as well as the group trend for the total Tau biomarker. The investigators will also study the effect of BCG vaccination on the dynamics of the cognitive performance of the selected individuals. The investigators hypothesize that BCG vaccination in individuals with high-risk pre-symptomatic Alzheimer's disease will reduce active brain disease, as determined by blood biomarkers' levels and will mitigate cognitive decline. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05407272 -
Explore the Sharing Model Intervene to Improve the Knowledge, Attitudes, Service Intentions and Service Start-up Effects of the Eight Major Non-cancer Disease End-stage Caregivers on Well-being and Palliative Care
|
N/A | |
Completed |
NCT02958930 -
Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease
|
N/A | |
Completed |
NCT04449926 -
BCG and Plasma Amyloid in Non-Demented Adults
|
Phase 2 | |
Recruiting |
NCT06203106 -
NYSCF Scientific Discovery Biobank
|
||
Active, not recruiting |
NCT03661034 -
Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
|
N/A | |
Not yet recruiting |
NCT05183516 -
Tdap and Biomarkers of Alzheimer's Disease
|
Phase 1/Phase 2 | |
Recruiting |
NCT04263194 -
Network-based rTMS in Alzheimer's Disease
|
N/A | |
Recruiting |
NCT04100889 -
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease
|
||
Completed |
NCT02187276 -
The Predictive Factors of Good Clinical Response to Cholinesterase Inhibitors in Alzheimer Disease and Mixed Dementia
|
N/A | |
Recruiting |
NCT04680013 -
Genetic Studies in Familial Dementia
|
||
Recruiting |
NCT04270474 -
Reducing Risk of Dementia Through Deprescribing
|
N/A | |
Not yet recruiting |
NCT06448403 -
Multimodal Assesment of Alzheimer Patients
|
||
Recruiting |
NCT05138848 -
Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease
|
N/A | |
Withdrawn |
NCT03149380 -
Effectiveness of Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior
|
N/A | |
Recruiting |
NCT03653156 -
China Cognition and Aging Study
|
||
Completed |
NCT03300726 -
Synaptic Injury and Functional Connectivity in Alzheimer's Disease
|
||
Recruiting |
NCT01773915 -
New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study
|
N/A | |
Recruiting |
NCT05655195 -
Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy
|
N/A | |
Recruiting |
NCT05637801 -
A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
|
N/A | |
Recruiting |
NCT03153371 -
Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks
|