دورية أكاديمية
Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease:study protocol for a randomised controlled trial (ELAD study)
| العنوان: | Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer's disease:study protocol for a randomised controlled trial (ELAD study) |
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| المؤلفون: | Femminella, Grazia Daniela, Frangou, Eleni, Love, Sharon B, Busza, Gail, Holmes, Clive, Ritchie, Craig, Lawrence, Robert, McFarlane, Brady, Tadros, George, Ridha, Basil H, Bannister, Carol, Walker, Zuzana, Archer, Hilary, Coulthard, Elizabeth, Underwood, Ben R, Prasanna, Aparna, Koranteng, Paul, Karim, Salman, Junaid, Kehinde, McGuinness, Bernadette, Nilforooshan, Ramin, Macharouthu, Ajay, Donaldson, Andrew, Thacker, Simon, Russell, Gregor, Malik, Naghma, Mate, Vandana, Knight, Lucy, Kshemendran, Sajeev, Harrison, John, Brooks, David J, Passmore, Anthony Peter, Ballard, Clive, Edison, Paul |
| المصدر: | Femminella , G D , Frangou , E , Love , S B , Busza , G , Holmes , C , Ritchie , C , Lawrence , R , McFarlane , B , Tadros , G , Ridha , B H , Bannister , C , Walker , Z , Archer , H , Coulthard , E , Underwood , B R , Prasanna , A , Koranteng , P , Karim , S , Junaid , K , McGuinness , B , Nilforooshan , R , Macharouthu , A , Donaldson , A , Thacker , S .... |
| سنة النشر: | 2019 |
| المجموعة: | University of Bristol: Bristol Reserach |
| مصطلحات موضوعية: | Alzheimer's disease, Dementia, Randomised controlled trial, Liraglutide, Cerebral glucose metabolic rate |
| الوصف: | BACKGROUND: Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue currently approved for type 2 diabetes and obesity. Preclinical evidence in transgenic models of Alzheimer's disease suggests that liraglutide exerts neuroprotective effects by reducing amyloid oligomers, normalising synaptic plasticity and cerebral glucose uptake, and increasing the proliferation of neuronal progenitor cells. The primary objective of the study is to evaluate the change in cerebral glucose metabolic rate after 12 months of treatment with liraglutide in participants with Alzheimer's disease compared to those who are receiving placebo. METHODS/DESIGN: ELAD is a 12-month, multi-centre, randomised, double-blind, placebo-controlled, phase IIb trial of liraglutide in participants with mild Alzheimer's dementia. A total of 206 participants will be randomised to receive either liraglutide or placebo as a daily injection for a year. The primary outcome will be the change in cerebral glucose metabolic rate in the cortical regions (hippocampus, medial temporal lobe, and posterior cingulate) from baseline to follow-up in the treatment group compared with the placebo group. The key secondary outcomes are the change from baseline to 12 months in z scores for clinical and cognitive measures (Alzheimer's Disease Assessment Scale-Cognitive Subscale and Executive domain scores of the Neuropsychological Test Battery, Clinical Dementia Rating Sum of Boxes, and Alzheimer's Disease Cooperative Study-Activities of Daily Living) and the incidence and severity of treatment-emergent adverse events or clinically important changes in safety assessments. Other secondary outcomes are 12-month change in magnetic resonance imaging volume, diffusion tensor imaging parameters, reduction in microglial activation in a subgroup of participants, reduction in tau formation and change in amyloid levels in a subgroup of participants measured by tau and amyloid imaging, and changes in composite scores using support machine vector analysis in the treatment group ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://research-information.bris.ac.uk/en/publications/744741ab-4b59-4749-ac57-21ccc5d2e70aTest |
| DOI: | 10.1186/s13063-019-3259-x |
| الإتاحة: | https://doi.org/10.1186/s13063-019-3259-xTest https://hdl.handle.net/1983/744741ab-4b59-4749-ac57-21ccc5d2e70aTest https://research-information.bris.ac.uk/en/publications/744741ab-4b59-4749-ac57-21ccc5d2e70aTest https://research-information.bris.ac.uk/ws/files/205792620/document_14_.pdfTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.47998B64 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13063-019-3259-x |
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