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Background: Mibampator, an amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor potentiator, was evaluated for treatment of agitation and aggression (A/A) in Alzheimer's disease (AD).
Methods: Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatment with 3-mg po mibampator or placebo were assessed using the 4-domain A/A subscale of the Neuropsychiatric Inventory (NPI-4-A/A) derived from the Neuropsychiatric Inventory. Secondary measures included the Cohen-Mansfield Agitation Inventory, Cornell Scale for Depression in Dementia, Frontal Systems Behavior Inventory (FrSBe), and Alzheimer's Disease Assessment Scale-Cognitive. Efficacy was analyzed using mixed-effects model repeated measures from baseline to endpoint. Adverse events (AEs), labs, vital signs, and electrocardiograms were monitored.
Results: Baseline characteristics were comparable between groups. Both groups improved on the NPI-4-A/A, but without group differences. Among secondaries, mibampator was significantly better (p = 0.007) than placebo only on the FrSBe. AEs were similar between groups. One death occurred in the placebo group.
Conclusion: Possible explanations for no significant group differences include caregiver, drug target engagement, and design issues.
This trial is registered on ClinicalTrials.gov; ID: NCT00843518.
Acute chest pain is the presenting complaint in roughly 3% of emergency department (ED) patients. The diagnostic possibilities range from the immediately life-threatening (myocardial infarction (MI), unstable angina (USA), aortic dissection (AD), pulmonary embolism (PE), ruptured esophagus) to the self-limiting (chest wall strain), and the common (gastroesophageal reflux disease) to the unusual (herpes zoster). Although the etiology of the chest pain may remain unidentified in a significant proportion of patients, which can be frustrating to both the patient and provider, it is imperative that the clinician recognizes and treats life-threatening causes.
When considering the differential diagnosis of the patient with chest pain, it is helpful to consider the five organ systems in the thorax: cardiac (heart and pericardium), pulmonary (lungs and pleura), gastrointestinal (esophagus and upper abdominal contents), vascular (aorta and great vessels), and musculoskeletal (chest wall). Visceral pain from internal structures such as the heart, lungs, esophagus, and aorta may be difficult for the patient to define. Pain may be described as a discomfort or strange sensation, and it is often challenging for the patient to discern an exact location. Somatic pain, from chest wall structures, is often more localizable and easier for the patient to characterize. Pain may be sharp or stabbing, brought on by movement or position, and can often be pinpointed. Referred pain, from irritation or inflammation of the upper abdominal contents, may be perceived as pain in the chest or upper back.
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