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Seltorexant for Alzheimer's Disease
Study Summary
This trial will compare the effect of seltorexant to placebo on reducing agitation and aggression in Alzheimer's patients.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You experienced confusion or disorientation within the past month or during the screening process.Your body mass index (BMI) falls between 18 and 40 kilograms per square meter (kg/m^2).You have a history of aggressive behavior not related to dementia, or your agitation is caused by something other than dementia, such as pain.You have been diagnosed with a condition called "agitation" by a medical professional specializing in cognitive disorders and this diagnosis has lasted for at least 2 weeks before the start of the screening process.
- Group 1: Placebo
- Group 2: Seltorexant
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who meets the specific requirements to be included in this research project?
"This study is looking for 86 patients that currently suffer from Alzheimer's disease and meet the following criteria: They must be between the ages of 55 and 85, have a Clinical Dementia Rating (CDR) global score of 2 or higher, aMini-Mental State Examination (MMSE) total score between 10 and 24, meet the criteria of a syndrome diagnosis of agitation based on International Psychogeriatric Association (IPA) consensus clinical and research definition of agitation in cognitive disorders for at least 2 weeks before screening, have a Neuropsychiatric Inventory (NPI-12) Agitation/Aggression (A"
How many people fit the bill for this clinical trial?
"From what is posted on clinicaltrials.gov, it seems that the research team is actively looking for participants. The trial was first announced on May 19th, 2022 and updated as recently as November 9th, 2022. They are currently seeking 86 individuals from across 31 different locations."
Are we still able to enroll people in this research project?
"That is correct. The trial, which was first posted on May 19th, 2020, is currently looking for 86 patients at 31 different locations around the world."
Is this study only for people under 45 years old?
"According to the research requirements, patients who want to enroll in this clinical trial must be between 55 and 85 years old. There are 23 studies for people under 18 and 552 trials for senior citizens aged 65 or older."
Has Seltorexant met the Food and Drug Administration's requirements for use?
"While Phase 2 trials lack the efficacy data of later stages, there is some evidence supporting Seltorexant's safety."
How many different areas are conducting this research project?
"Accel Clinical Research (Saint Petersburg, FL), Global Medical Institutes (Miami, CA), Sunwise Clinical Research (Phoenix, TX), and 31 other clinical research sites are participating in this trial."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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