Here’s a breakdown of the provided text, focusing on the key data about the Alzheimer’s Association’s guidelines:
About the Alzheimer’s Association:
Mission: To lead the way to end Alzheimer’s and all other cognitive impairments by accelerating research, promoting risk reduction, early detection, and providing quality treatment and support.
Vision: A world free of Alzheimer’s disease and all other dementias.
Contact:
Website: alz.org
Phone: 800.272.3900
Guidelines for the Use of Empirical Clinical Practice Based on Blood Biomarkers and Cognitive Tests to Detect and Diagnose Cognitive Impairments:
Proposal Number: 108894
Presentation: Oral Report on Tuesday, July 29, 2025, from 2:00 pm to 3:30 pm EDT.
Specific Guidelines for Clinical Practice of Blood Biomarkers for the Diagnosis of Alzheimer’s Disease in Special Care settings:
Background:
Blood biomarkers (BBMs) are transforming Alzheimer’s disease (AD) diagnosis.
Some BBMs are nearing clinical implementation.
There’s a growing need for precise early diagnosis, especially with new anti-Aβ therapies for early asymptomatic AD.
The Alzheimer’s Association assembled a multidisciplinary team to review literature and create evidence-based recommendations for BBM use in AD diagnosis.
These guidelines are primarily for patients with mild cognitive impairment (MCI) or dementia in second or third-tier medical care settings.
Methodology:
A systematic literature review was conducted.
The review evaluated the diagnostic accuracy of BBMs for detecting amyloid pathology (sensitivity ≥ 90%, specificity ≥ 75%) and confirming AD diagnosis (sensitivity and specificity ≥ 90%).
Key BBMs analyzed: plasma p-tau (p-tau217, %p-tau217, p-tau181, p-tau231) and Aβ42/Aβ40 ratios.
Reference standard tests: CSF, amyloid PET, or neuropathological examination.
The GRADE method was used to assess evidence accuracy and make recommendations (“from evidence to decision” framework).
Results:
49 observational studies were evaluated, covering 31 different BBM tests.
Tests were categorized based on their diagnostic accuracy:
1. Sufficient for screening: Positive results require confirmation by PET or CSF.
2. sufficient for confirmation: Can replace PET or CSF.3. Insufficient for current clinical practice.
Recommendations will be provided for any BBMs meeting the predefined diagnostic test accuracy cutoffs.
Conclusion:
BBMs have the potential to improve early AD diagnosis and expand access to disease-modifying therapies.
Evidence-based guidelines are crucial for standardizing BBM use.
* These guidelines will be updated as new evidence and applications emerge.
