https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(06)68880-6.pdf

Mild cognitive impairment

Mild cognitive impairment (MCI) is a controversial label for forms of age-related, intellectual difficulties unassociated with impairments in activities of daily living. The principal issue is whether this arbitrary, heterogeneous and unreliable term is appropriate to use clinically. Persons with the label MCI may progress to different types of dementia, stay stable, or even improve. In this article we offer a philosophical analysis of MCI from epistemological, ethical and semantic perspectives. We believe that the term should currently not be used clinically.

Mild cognitive impairment A ‘hardening of the categories’?

Summary Early diagnosis of Alzheimer's disease (AD) is needed to initiate symptomatic treatment with acetylcholinesterase inhibitors, and will be of even greater significance if drugs aimed at slowing down the degenerative process, such as vaccination regimes and β-secretase and γ-secretase inhibitors, prove to affect AD pathology and to have clinical effect. However, there is no clinical method to determine in which patients mild cognitive impairment (MCI) will progress to AD with dementia, and in which patients MCI is benign. Hence, there is a great clinical need for biomarkers to identify incipient AD in patients with MCI. The CSF biomarkers total tau protein, phosphorylated tau protein, and the 42 amino-acid residue form of amyloid-β may, if put in the right clinical context, prove to have high enough diagnostic accuracy to meet this challenge.

https://www.thelancet.com/pdfs/journals/laneur/PIIS1474-4422(03)00530-1.pdf

CSF markers for incipient Alzheimer's disease

Advances in therapeutic strategies for Alzheimer's disease that lead to even small delays in onset and progression of the condition would significantly reduce the global burden of the disease To effectively test compounds for Alzheimer's disease and bring therapy to individuals as early as possible there is an urgent need for collaboration between academic institutions, industry and regulatory organizations for the establishment of standards and networks for the identification and qualification of biological marker candidates Biomarkers are needed to monitor drug safety, to identify individuals who are most likely to respond to specific treatments, to stratify presymptomatic patients and to quantify the benefits of treatments Biomarkers that achieve these characteristics should enable objective business decisions in portfolio management and facilitate regulatory approval of new therapies

Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives

Several potential disease-modifying drugs for Alzheimer's disease (AD) have failed to show any effect on disease progression in clinical trials, conceivably because the AD subjects are already too advanced to derive clinical benefit from treatment and because diagnosis based on clinical criteria alone introduces a high misdiagnosis rate. Thus, well-validated biomarkers for early detection and accurate diagnosis are crucial. Low cerebrospinal fluid (CSF) concentrations of the amyloid-β (Aβ 1-42 ) peptide, in combination with high total tau and phosphorylated tau, are sensitive and specific biomarkers highly predictive of progression to AD dementia in patients with mild cognitive impairment. However, interlaboratory variations in the results seen with currently available immunoassays are of concern. Recent worldwide standardization efforts and quality control programs include standard operating procedures for both preanalytical (e.g., lumbar puncture and sample handling) and analytical (e.g., preparation of calibration curve) procedures. Efforts are also ongoing to develop highly reproducible assays on fully automated instruments. These global standardization and harmonization measures will provide the basis for the generalized international application of CSF biomarkers for both clinical trials and routine clinical diagnosis of AD.

/pdf/clinical-utility-of-cerebrospinal-fluid-biomarkers-in-the-hm6zjf7gmk.pdf

Clinical utility of cerebrospinal fluid biomarkers in the diagnosis of early Alzheimer's disease.

Longitudinal cerebrospinal fluid tau load increases in mild cognitive impairment.

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Longitudinal cerebrospinal fluid tau load increases in mild cognitive impairment.