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Orexin Antagonist
Suvorexant for Alzheimer's Disease (SToP-AD Trial)
Phase 2
Recruiting
Led By Brendan Lucey, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be age ≥65 years and able to sign informed consent
Capacity to give informed consent and follow study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 214 months
Awards & highlights
SToP-AD Trial Summary
This trial will test if suvorexant can help slow the accumulation of amyloid-β in the brain, a protein associated with Alzheimer's disease.
Who is the study for?
This trial is for individuals aged 65 or older with early signs of Alzheimer's, as indicated by specific brain scan results and cognitive assessments. They must be able to consent and follow study procedures. Excluded are those with certain sleep disorders, severe health conditions, recent substance abuse, high alcohol intake, obesity (BMI >35), or on conflicting medications.Check my eligibility
What is being tested?
The trial tests if suvorexant, a sleep aid medication at a dose of 20 mg, can slow down the buildup of amyloid-β in the brain compared to a placebo. Amyloid-β accumulation is associated with Alzheimer's disease progression.See study design
What are the potential side effects?
Suvorexant may cause drowsiness during daytime, headaches, dizziness or lightheadedness when getting up too quickly from lying down/sitting position (orthostatic hypotension), abnormal dreams or nightmares.
SToP-AD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 or older and can give my consent.
Select...
I understand the study and can follow its procedures.
SToP-AD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 214 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~214 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Amyloid-β accumulation detected by plasma pT217/T217 compared to placebo
Secondary outcome measures
Change in CSF Amyloid-β compared to placebo
Change in CSF p-tau compared to placebo
Change in CSF tau compared to placebo
+8 moreSToP-AD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Poor sleep treatment groupExperimental Treatment1 Intervention
100 participants will be randomized to take suvorexant 20mg daily at h.s. for two years
Group II: Poor sleep control gropPlacebo Group1 Intervention
100 participants will be randomized to take placebo daily at h.s. for two years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant 20 mg
2019
Completed Phase 4
~70
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,610 Total Patients Enrolled
Good Ventures FoundationUNKNOWN
Merck Sharp & Dohme LLCIndustry Sponsor
3,890 Previous Clinical Trials
5,060,101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been drinking alcohol regularly, at least 3 days a week for the past 6 months, and typically have more than 2 drinks within 3 hours of going to bed. If you agree to drink less during the study, this rule may not apply to you.I use a PAP machine for my sleep disorder or my AHI score is over 15.My sleep efficiency is 85% or higher.Your blood test shows normal levels of amyloid-beta.I am 65 or older and can give my consent.I understand the study and can follow its procedures.I have a sleep disorder other than insomnia.My non-dominant arm moves abnormally.My liver tests are more than twice the normal range.I have chronic kidney disease with an eGFR under 60.Your PET scan shows a certain level of brain activity between a specific range.I have had a stroke.You weigh more than what is considered healthy for your height.I am living with HIV/AIDS.You have struggled with drug or alcohol abuse in the past 6 months.My gender or race does not limit my participation.Your STOP-Bang score is 5 or higher.You do not have any signs of dementia according to a medical assessment called Global Clinical Dementia Rating (CDR).
Research Study Groups:
This trial has the following groups:- Group 1: Poor sleep treatment group
- Group 2: Poor sleep control grop
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any other experimental trials been conducted with Suvorexant 20 mg?
"Currently, 14 trials investigating Suvorexant 20 mg are in progress with 2 of them being Phase 3. Although most research is conducted at Silver Spring, Maryland, 71 different locations across the globe have studies for this medication underway."
Answered by AI
Are there any openings available for participants in this clinical trial?
"It appears that patients are being recruited for this trial according to clinicaltrials.gov, with a primary posting date of May 25th 2022 and an update on November 15th 2022."
Answered by AI
How many participants are actively engaging with this trial?
"Affirmative. Per the information provided on clinicaltrials.gov, this research endeavor is actively seeking participants as of November 15th 2022 - a date that marks its last update since being posted on May 25th 2022. 200 individuals need to be enrolled from one location for the study's completion."
Answered by AI
Has Suvorexant 20 mg obtained regulatory approval from the FDA?
"Suvorexant 20 mg was assigned a safety score of 2, as the drug has been tested in Phase 2 trials and there is some evidence for its security but no information confirming efficacy."
Answered by AI
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