NCT03706989 - Clinical Trial References

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.

Citation(s)

Brown EN, Purdon PL
The aging brain and anesthesia. Curr Opin Anaesthesiol. 2013 Aug;26(4):414-9. doi: 10.1097/ACO.0b013e328362d183.
de Waal H, Stam CJ, de Haan W, van Straaten EC, Blankenstein MA, Scheltens P, van der Flier WM
Alzheimer's disease patients not carrying the apolipoprotein E epsilon4 allele show more severe slowing of oscillatory brain activity. Neurobiol Aging. 2013 Se
Evered L, Silbert B, Scott DA, Zetterberg H, Blennow K
Association of Changes in Plasma Neurofilament Light and Tau Levels With Anesthesia and Surgery: Results From the CAPACITY and ARCADIAN Studies. JAMA Neurol. 2018 May 1;75(5):542-547. doi: 10.1001/ja
Giattino CM, Gardner JE, Sbahi FM, Roberts KC, Cooter M, Moretti E, Browndyke JN, Mathew JP, Woldorff MG, Berger M; MADCO-PC Investigators
Intraoperative Frontal Alpha-Band Power Correlates with Preoperative Neurocognitive Function in Older Adults. Front
Halaas NB, Blennow K, Idland AV, Wyller TB, Raeder J, Frihagen F, Staff AC, Zetterberg H, Watne LO
Neurofilament Light in Serum and Cerebrospinal Fluid of Hip Fracture Patients with Delirium. Dement Geriatr Cogn Disord. 2018;46(5-6):346-357. doi: 10.1159
Vasunilashorn S, Ngo L, Kosar CM, Fong TG, Jones RN, Inouye SK, Marcantonio ER
Does Apolipoprotein E Genotype Increase Risk of Postoperative Delirium? Am J Geriatr Psychiatry. 2015 Oct;23(10):1029-1037. doi: 10.1016/j.jagp.2014.12.192. Epub 2015 May 21.

Predicting Postoperative Delirium Using Intraoperative EEG Alpha Wave Analysis, APOE Genotyping and NfL as a Biomarker of Cerebral Injury

Clinical trial NCT03706989 - References