SToP-ADSuvorexant for Amyloid-β Reduction in Alzheimer's Prevention
Suvorexant 20 mg
+ Placebo
Alzheimer Disease+13
+ Mental Disorders
+ Brain Diseases
Prevention Study
Summary
Study start date: May 25, 2022
Actual date on which the first participant was enrolled.This clinical trial is focused on finding out if the drug suvorexant can help prevent Alzheimer's disease by slowing down the build-up of a protein called amyloid-β in the brain. Amyloid-β is known to play a role in the development of Alzheimer's, which is a progressive brain disorder affecting memory and thinking skills. The study targets individuals who may be at risk of developing Alzheimer's, aiming to find new ways to delay or reduce the onset of this condition. By potentially reducing amyloid-β levels, this study could lead to new preventive treatments, which are currently limited. Participants in the study will receive either a 20 mg dose of suvorexant or a placebo. The treatment is administered orally. The main focus is to measure changes in amyloid-β levels using a blood test that detects specific proteins like pT217/T217. Blood samples are collected to see if there is a difference in amyloid-β accumulation between those taking suvorexant and those receiving a placebo. This helps researchers understand if suvorexant has the potential to slow down the disease process before symptoms appear.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Male or female. * Any race or ethnicity. * Participants must be age ≥65 years and able to sign informed consent. * Global Clinical Dementia Rating (CDR) 0. * Willing and able to undergo study procedures. Exclusion Criteria: * History of reported symptoms suggestive of restless legs syndrome, narcolepsy or other central disorder of hypersomnolence, or parasomnia * STOP-Bang score \>6 for participants without PAP * Untreated OSA with AHI ≥15 on home sleep test * Treated sleep apnea with PAP non-compliance * PAP compliance is defined as \>= 4 hours per night \>70% of the nights * Plasma A-beta and tau test with a plasma p-tau 217% ≤ 1.19 * Stroke. * Chronic kidney disease defined as patients with markers of kidney damage or eGFR of \< 45 ml/min/1.73m2. * Hepatic impairment defined as AST and/or ALT \> 2x upper limit of normal (normal limits AST: 11-47 IU/L, ALT: 6-53 IU/L). * HIV/AIDS. * History of substance abuse or alcohol abuse in the proceeding 6 months. * Regular alcohol consumption 3 or more days a week over the last 6 months. Regular alcohol consumption is defined as having more than 2 alcoholic beverages within 3 hours of bedtime. Participants that agree to reduce alcohol consumption during the study may not be excluded. * History of presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or participant report that could affect the safety of the participant or interfere with study assessments or in the judgement of the Principal-Investigator (PI) if participant is not a good candidate. * Has any medical condition that, in the PI's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data. Potential medical conditions that will be exclusionary at the PI's discretion: * Cardiovascular disease requiring medication except for controlled hypertension. * Pulmonary disease. * Type I diabetes. * Neurologic or psychiatric disorder requiring medication. * Tobacco use. * Use of sedating medications. * Use of medications that interact with suvorexant (if cannot be discontinued) * Abnormal safety labs * History of current suicidal ideations. * Currently pregnant or breast-feeding. * In the opinion of the PI, the participant should be excluded due to an abnormal physical examination. * Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment. * Must not participate in another drug or device study prior to the end of this study participation. Exclusion criteria for optional lumbar punctures -• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Washington University School of Medicine
St Louis, United StatesOpen Washington University School of Medicine in Google Maps