Breakthrough Clinical Results
Labcorp announced the nationwide availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood test for Alzheimer's disease. This blood-based in-vitro diagnostic (IVD) test aids in diagnosis by detecting amyloid plaques associated with the disease. The test offers a less invasive and more affordable alternative to existing methods like CSF testing and PET scans, providing results comparable in accuracy. Developed by Fujirebio Diagnostics, the test is intended for adults aged 50 and older showing cognitive decline symptoms and must be used in conjunction with other clinical information. The launch aligns with a new Alzheimer's Association clinical guideline supporting blood-based biomarkers for Alzheimer's evaluation.
Key Highlights
- First FDA-cleared blood test for Alzheimer's disease.
- Offers a less invasive and more affordable alternative to CSF testing and PET scans.
- Demonstrated high positive (92%) and negative (97%) predictive values in clinical studies.
- Nationwide availability through Labcorp's extensive network.
Incidence and Prevalence
Global Estimates of Alzheimer's Disease Incidence and Prevalence
According to the Global Burden of Disease (GBD) 2021 database, global Alzheimer's disease (AD) cases have more than doubled from 4.078 million to 9.837 million between 1992 and 2021. Despite this significant increase in absolute numbers, the global age-standardised incidence rate (ASIR) has remained relatively stable, showing only a slight increase from 117.7 to 119.8 per 100,000 during this period.
Projections indicate a continued dramatic rise, with global AD cases expected to reach 19.117 million by 2036, accompanied by a substantial increase in ASIR to 418.92 per 100,000.
The burden of Alzheimer's disease varies significantly across different regions and demographic groups:
- Regional variations: The ASIR has increased significantly in high-middle and middle-sociodemographic index regions but has declined in low-sociodemographic index regions.
- Gender disparities: Women consistently exhibit higher incidence rates than men across all regions globally.
- Age-related patterns: In France, prevalence increases markedly with age, from approximately 0.1 percent between 55-65 years, to 1 percent between 65-74 years, and reaching 10 percent beyond 85 years.
In specific countries and regions: - United States: An estimated 6.2 million Americans age 65 and older are living with Alzheimer's dementia (as of 2021), with projections suggesting this could reach 13.8 million by 2060 without medical breakthroughs. - Spain: The prevalence ranges between 4-11% for the population over 65 years (as of 2010). - Rural Korea: The adjusted prevalence of dementia was estimated at 9.5%, with age-standardized prevalence of Alzheimer's disease at 4.5% (as of 1998). - Western Poland: The prevalence rate was 1105.7 per 100 thousand overall, but reached 10059.2 per 100 thousand in persons over 65 years (1991 data).
Racial and ethnic disparities exist in dementia burden and care. Blacks, Hispanics, Asian Americans, and Native Americans have a higher burden of illness and lower access to health care compared to Whites. In a Colombian study, African ancestry was associated with an increased late-onset Alzheimer's disease risk (odds ratio: 1.55), whereas Native American ancestry was associated with lower risk (odds ratio: 0.75).
The global prevalence of Alzheimer's disease is estimated at 24 million cases, making it the most common form of dementia among the elderly, accounting for at least two-thirds of all dementia cases.
While the global ASIR has remained relatively stable, the absolute number of AD cases continues to rise primarily due to population aging, particularly in middle- and high-income regions. This trend presents significant challenges for healthcare systems worldwide, especially in low-income regions with limited healthcare resources.
Risk Factors and Comorbidities
Top 3 Risk Factors and Comorbidities for Alzheimer's Disease
1. Genetic Factors
The APOE ε4 allele stands as a major genetic risk factor for Alzheimer's disease (AD), regardless of age of onset or family history. Individuals carrying two E4 alleles have significantly increased risk (OR = 5.6) compared to those with the E3/E3 genotype. Even one E4 allele increases risk substantially (OR = 2.5). Conversely, the APOE ε2 allele appears to offer a protective effect against AD. Genetic predisposition is further evidenced by presenilin-1 (PS1) mutations linked to autosomal dominant forms of AD. Family history also plays a crucial role, with first-degree relatives of language-disordered or apractic AD probands showing a 90-year lifetime incidence of dementia exceeding 50% - seven times higher than control values.
2. Cardiovascular and Metabolic Factors
Cardiovascular risk factors show strong associations with AD development. These include high blood pressure (highest prevalence at 49.9% among modifiable risk factors), with both systolic and diastolic blood pressure showing significant correlation with AD biomarkers (r = 0.19, p = 0.002 and r = 0.16, p = 0.007 respectively). Other significant cardiovascular factors include pulse pressure, total cholesterol, and triacyl glycerol. Diabetes is another major risk factor, with hemoglobin A1c levels correlating with plasma Abeta1-42 concentrations. Atherosclerosis has been suggested to contribute to the development of dementia of the Alzheimer's type. Obesity has also been linked to AD, with research identifying "intricate correlations between AD and body composition."
3. Inflammatory and Immunological Factors
Recent research highlights that inflammation and immunonutritive status play important roles in AD pathogenesis. Inflammatory markers are significantly higher in AD patients compared to control groups, including neutrophil count, C-reactive protein (CRP) levels, and inflammatory burden index (IBI). Conversely, immunonutritive markers are significantly lower in AD patients, including hemoglobin, lymphocyte count, albumin level, and HALP score. Age, HALP score, and IBI were found to be predictors for the severity of cognitive impairment.
Additional Significant Factors
Age remains a fundamental risk factor for AD, as evidenced by the correlation between plasma Abeta1-42 concentrations and age categories. Modifiable lifestyle factors also contribute significantly to AD risk, including not meeting aerobic physical activity guidelines, depression, current cigarette smoking, hearing loss, and binge drinking. The prevalence of subjective cognitive decline (SCD), an early indicator of possible future AD, increases dramatically from 3.9% among adults with no risk factors to 25.0% among those with four or more risk factors.
Racial and demographic factors also modify AD risk, with racial differences occurring at different ages depending on APOE ε4 status and body mass index (BMI).
Drug used in other indications
Insufficient Data on Lumipulse® pTau-217/Beta Amyloid 42 Ratio Trials Beyond Alzheimer's Disease
After thorough examination, no specific information is available regarding the use of Lumipulse® pTau-217/Beta Amyloid 42 Ratio in clinical trials for indications other than Alzheimer's disease. The current data does not reveal any details about alternative clinical applications of this diagnostic biomarker test in non-Alzheimer's conditions.
Similarly, there is no documented information about the intervention models or study designs being used in trials of this specific biomarker ratio for other neurological or neurodegenerative disorders.
The Lumipulse® assay combining phosphorylated Tau protein 217 and Beta Amyloid 42 measurements appears to be primarily focused on Alzheimer's disease diagnosis based on available information, with no clear evidence of expansion into other clinical indications at this time.
Research into alternative applications of this particular biomarker ratio may be ongoing but is not reflected in the current data. The diagnostic utility of this specific test combination outside the Alzheimer's disease context remains undocumented in the available information.