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Lemborexant for Alzheimer's Disease
Study Summary
This trial will examine how a new sleep drug impacts Alzheimer's disease biomarkers in poor sleepers' brain and blood.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 1 trial • 146 Patients • NCT03471871Trial Design
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Who is running the clinical trial?
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- You have a history of poor memory and thinking skills as shown by a test score lower than 27.You have a sleep disorder other than insomnia.You have a history of serious sleeping problems and your STOP-Bang score is higher than 5.You have a history or symptoms that suggest you have trouble with restless legs, narcolepsy, or other sleep problems.You have only mild sleep apnea, with an Apnea-Hypopnea Index (AHI) of less than 16 on a sleep study.Your bedtime is either earlier than 10:00 PM or later than midnight.You cannot have a lumbar catheter if you take blood thinners, have a bleeding disorder, are allergic to lidocaine or disinfectant, or have had surgery on your lower back or central nervous system.You have a heart condition that needs medication, except for controlled high blood pressure.You have had a stroke.You have liver or kidney problems.The decision to include participants with lung disease is up to the principal investigator.You are between 60 and 80 years old.You have type 1 diabetes.You have HIV or AIDS.You have thoughts of hurting yourself.You are not able to get out of bed by yourself.You are currently pregnant.You have a very high body weight for your height.You have a history of migraines, and the principal investigator will decide if you can participate.You have used illegal drugs in the past 6 months.You have trouble controlling your urine or bowel movements.Your Mini-Mental Status Examination score (MMSE) should be 27 or higher.You have a positive amyloid-beta test in your blood.You have a Pittsburgh Sleep Quality Index score higher than 5.You have a neurological or psychiatric disorder that needs medication, as decided by the principal investigator.
- Group 1: treatment
- Group 2: placebo
- 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
Does the medical study include applicants aged 40 and above?
"The parameters for this trial requires that the participants are between 60 to 80 years of age. Separately, there are 20 clinical trials specifically suited for younger individuals and 529 studies available to those who have surpassed 65 years old."
Has the treatment been approved by federal regulators?
"Based on our team's assessment, the treatment can be rated as a 2 in terms of safety. This is because Phase 2 trials usually have some evidence highlighting its security profile but not enough to demonstrate efficacy."
Are there any open enrollment opportunities for this research study?
"As confirmed by clinicaltrials.gov, this medical study is currently not enrolling new patients; the trial first appeared on February 1st of 2023 and was last updated five days later. Despite this particular research project being inactive, there are presently 538 other trials that are actively recruiting participants."
Who has been approved to partake in this research endeavor?
"For this research project, investigators are seeking 30 individuals between the ages of 60 and 80 who have been diagnosed with Alzheimer's disease. Furthermore, these potential participants must also meet a certain set of criteria including: age range specified above, gender does not matter; any race/ethnicity is accepted; MMSE score of 27 or higher; an amyloid-positive plasma test result; and Pittsburgh Sleep Quality Index greater than 5."
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