Avgerinos KI, Ferrucci L, Kapogiannis D Effects of monoclonal antibodies against amyloid-beta on clinical and biomarker outcomes and adverse event risks: A systematic review and meta-analysis of phase III RCTs in Alzheimer's disease. Ageing Res Rev. 2021 Jul;68:101339. doi: 10.1016/j.arr.2021.101339. Epub 2021 Apr 5.
Chang YF, Zhang D, Hu WM, Liu DX, Li L Semaglutide-mediated protection against Abeta correlated with enhancement of autophagy and inhibition of apotosis. J Clin Neurosci. 2020 Nov;81:234-239. doi: 10.1016/j.jocn.2020.09.054. Epub 2020 Oct 14.
Cho Y, Han K, Kim DH, Park YM, Yoon KH, Kim MK, Lee SH Cumulative Exposure to Metabolic Syndrome Components and the Risk of Dementia: A Nationwide Population-Based Study. Endocrinol Metab (Seoul). 2021 Apr;36(2):424-435. doi: 10.3803/EnM.2020.935. Epub 2021 Apr 14.
Goke R, Larsen PJ, Mikkelsen JD, Sheikh SP Distribution of GLP-1 binding sites in the rat brain: evidence that exendin-4 is a ligand of brain GLP-1 binding sites. Eur J Neurosci. 1995 Nov 1;7(11):2294-300. doi: 10.1111/j.1460-9568.1995.tb00650.x.
Graf C The Lawton instrumental activities of daily living scale. Am J Nurs. 2008 Apr;108(4):52-62; quiz 62-3. doi: 10.1097/01.NAJ.0000314810.46029.74.
Hallschmid M, Benedict C, Schultes B, Born J, Kern W Obese men respond to cognitive but not to catabolic brain insulin signaling. Int J Obes (Lond). 2008 Feb;32(2):275-82. doi: 10.1038/sj.ijo.0803722. Epub 2007 Sep 11.
Heiss WD The Additional Value of PET in the Assessment of Cerebral Small Vessel Disease. J Nucl Med. 2018 Nov;59(11):1660-1664. doi: 10.2967/jnumed.118.214270. Epub 2018 Jun 29.
Heymann AD, Chodick G, Halkin H, Karasik A, Shalev V, Shemer J, Kokia E The implementation of managed care for diabetes using medical informatics in a large Preferred Provider Organization. Diabetes Res Clin Pract. 2006 Mar;71(3):290-8. doi: 10.1016/j.diabres.2005.07.002. Epub 2005 Aug 19.
Katsel P, Roussos P, Beeri MS, Gama-Sosa MA, Gandy S, Khan S, Haroutunian V Parahippocampal gyrus expression of endothelial and insulin receptor signaling pathway genes is modulated by Alzheimer's disease and normalized by treatment with anti-diabetic agents. PLoS One. 2018 Nov 1;13(11):e0206547. doi: 10.1371/journal.pone.0206547. eCollection 2018.
Kellar D, Lockhart SN, Aisen P, Raman R, Rissman RA, Brewer J, Craft S Intranasal Insulin Reduces White Matter Hyperintensity Progression in Association with Improvements in Cognition and CSF Biomarker Profiles in Mild Cognitive Impairment and Alzheimer's Disease. J Prev Alzheimers Dis. 2021;8(3):240-248. doi: 10.14283/jpad.2021.14.
Kim HW, Hong J, Jeon JC Cerebral Small Vessel Disease and Alzheimer's Disease: A Review. Front Neurol. 2020 Aug 25;11:927. doi: 10.3389/fneur.2020.00927. eCollection 2020.
Li A, Su X, Hu S, Wang Y Efficacy and safety of oral semaglutide in type 2 diabetes mellitus: A systematic review and meta-analysis. Diabetes Res Clin Pract. 2023 Apr;198:110605. doi: 10.1016/j.diabres.2023.110605. Epub 2023 Mar 5.
Lind M, Jendle J, Torffvit O, Lager I Glucagon-like peptide 1 (GLP-1) analogue combined with insulin reduces HbA1c and weight with low risk of hypoglycemia and high treatment satisfaction. Prim Care Diabetes. 2012 Apr;6(1):41-6. doi: 10.1016/j.pcd.2011.09.002. Epub 2011 Oct 19.
Love S, Miners JS Cerebrovascular disease in ageing and Alzheimer's disease. Acta Neuropathol. 2016 May;131(5):645-58. doi: 10.1007/s00401-015-1522-0. Epub 2015 Dec 28.
Novak P, Pimentel Maldonado DA, Novak V Safety and preliminary efficacy of intranasal insulin for cognitive impairment in Parkinson disease and multiple system atrophy: A double-blinded placebo-controlled pilot study. PLoS One. 2019 Apr 25;14(4):e0214364. doi: 10.1371/journal.pone.0214364. eCollection 2019.
Pal K, Mukadam N, Petersen I, Cooper C Mild cognitive impairment and progression to dementia in people with diabetes, prediabetes and metabolic syndrome: a systematic review and meta-analysis. Soc Psychiatry Psychiatr Epidemiol. 2018 Nov;53(11):1149-1160. doi: 10.1007/s00127-018-1581-3. Epub 2018 Sep 4.
Qiu M, Ding LL, Zhang M, Zhou HR Safety of four SGLT2 inhibitors in three chronic diseases: A meta-analysis of large randomized trials of SGLT2 inhibitors. Diab Vasc Dis Res. 2021 Mar-Apr;18(2):14791641211011016. doi: 10.1177/14791641211011016.
Rozga M, Bittner T, Batrla R, Karl J Preanalytical sample handling recommendations for Alzheimer's disease plasma biomarkers. Alzheimers Dement (Amst). 2019 Apr 2;11:291-300. doi: 10.1016/j.dadm.2019.02.002. eCollection 2019 Dec.
Seidu S, Kunutsor SK, Topsever P, Khunti K Benefits and harms of sodium-glucose co-transporter-2 inhibitors (SGLT2-I) and renin-angiotensin-aldosterone system inhibitors (RAAS-I) versus SGLT2-Is alone in patients with type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. Endocrinol Diabetes Metab. 2022 Jan;5(1):e00303. doi: 10.1002/edm2.303. Epub 2021 Oct 12.
Smits MM, Van Raalte DH Safety of Semaglutide. Front Endocrinol (Lausanne). 2021 Jul 7;12:645563. doi: 10.3389/fendo.2021.645563. eCollection 2021. Erratum In: Front Endocrinol (Lausanne). 2021 Nov 10;12:786732.
Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.
Wu JH, Haan MN, Liang J, Ghosh D, Gonzalez HM, Herman WH Impact of antidiabetic medications on physical and cognitive functioning of older Mexican Americans with diabetes mellitus: a population-based cohort study. Ann Epidemiol. 2003 May;13(5):369-76. doi: 10.1016/s1047-2797(02)00464-7.
Yoo H, Kim H, Koh I, Lee K, Ok J Effect of Metabolic Syndrome on the Incidence of Dementia Based on National Insurance Data in Korea. Metab Syndr Relat Disord. 2022 Feb;20(1):29-35. doi: 10.1089/met.2021.0046. Epub 2021 Nov 9.
Zuin M, Roncon L, Passaro A, Cervellati C, Zuliani G Metabolic syndrome and the risk of late onset Alzheimer's disease: An updated review and meta-analysis. Nutr Metab Cardiovasc Dis. 2021 Jul 22;31(8):2244-2252. doi: 10.1016/j.numecd.2021.03.020. Epub 2021 Apr 1.
Combination of Intranasal Insulin With Oral Semaglutide to Improve Cognition and Cerebral Blood Flow: a Feasibility Study
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.