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- Bischof, Gérard N., et al.
(författare)
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Clinical validity of second-generation tau PET tracers as biomarkers for Alzheimer’s disease in the context of a structured 5-phase development framework
- 2021
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Ingår i: European Journal of Nuclear Medicine and Molecular Imaging. - : Springer Science and Business Media LLC. - 1619-7070 .- 1619-7089. ; 48:7, s. 2110-2120
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Forskningsöversikt (refereegranskat)abstract
- Purpose: In 2017, the Geneva Alzheimer’s disease (AD) strategic biomarker roadmap initiative proposed a framework of the systematic validation AD biomarkers to harmonize and accelerate their development and implementation in clinical practice. Here, we use this framework to examine the translatability of the second-generation tau PET tracers into the clinical context. Methods: All available literature was systematically searched based on a set of search terms that related independently to analytic validity (phases 1–2), clinical validity (phase 3–4), and clinical utility (phase 5). The progress on each of the phases was determined based on scientific criteria applied for each phase and coded as fully, partially, preliminary achieved or not achieved at all. Results: The validation of the second-generation tau PET tracers has successfully passed the analytical phase 1 of the strategic biomarker roadmap. Assay definition studies showed evidence on the superiority over first-generation tau PET tracers in terms of off-target binding. Studies have partially achieved the primary aim of the analytical validity stage (phase 2), and preliminary evidence has been provided for the assessment of covariates on PET signal retention. Studies investigating of the clinical validity in phases 3, 4, and 5 are still underway. Conclusion: The current literature provides overall preliminary evidence on the establishment of the second-generation tau PET tracers into the clinical context, thereby successfully addressing some methodological issues from the tau PET tracer of the first generation. Nevertheless, bigger cohort studies, longitudinal follow-up, and examination of diverse disease population are still needed to gauge their clinical validity.
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| 2. |
- Vera, Jaime H, et al.
(författare)
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CLINICAL UTILITY OF β-AMYLOID PET IMAGING IN PEOPLE LIVING WITH HIV WITH COGNITIVE SYMPTOMS.
- 2021
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Ingår i: Journal of acquired immune deficiency syndromes (1999). - 1944-7884. ; 87:2, s. 826-833
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Tidskriftsartikel (refereegranskat)abstract
- Imaging with β-amyloid (Aβ) PET has the potential to aid the diagnosis of the cause of cognitive impairment affecting people living with HIV (PLWH) when neurodegenerative disorders are considered. We evaluated the clinical utility of [18F]Florbetaben (FBB) in PLWH with cognitive symptoms.Imaging with FBB PET was performed in 20 patients with cognitive concerns about dementia. Neuropsychological testing, plasma neurofilament light protein, plasma Aβ40, Aβ42 and CSF Aβ42, tau, and HIV RNA were obtained. FBB PET images were assessed visually by three readers blinded to the clinical diagnosis, and quantitatively by obtaining a composite cortical to cerebellar cortex standardized uptake value ratio (SUVR). FBB SUVR from 10 age-matched healthy controls were compared to SUVR of PLWH.Most participants were male (90%) of white ethnicity (90%) with a median age (IQR) of 59 (43-79) years. Median CD4 count was 682 (74-1056). All patients were on cART with plasma and CSF HIV RNA< 40 copies/mL. Fourteen patients had objective cognitive impairment including two who met clinical criteria for a diagnosis of dementia. No significant differences in composite SUVRs between PLWH and controls [mean (SD): 1.18 (0.03) vs 1.16 (0.09); p=0.37] were observed. Four patients were FBB+ with the highest SUVR in the posterior cingulate, superior temporal and frontal superior lobe. Amyloid PET results contributed to a change in diagnosis and treatment for 10 patients.[18F]Florbetaben PET has potential as an adjunctive tool in the diagnosis of PLWH with cognitive impairment, increasing diagnostic certainty and optimizing management.
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