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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
Must not have
Sleep disordered breathing if treated with PAP or AHI >15
Actigraphic sleep efficiency ≥85%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 214 months
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.
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.
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.
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.
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I understand the study and can follow its procedures.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I use a PAP machine for my sleep disorder or my AHI score is over 15.
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My sleep efficiency is 85% or higher.
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I have a sleep disorder other than insomnia.
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My liver tests are more than twice the normal range.
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I have chronic kidney disease with an eGFR under 60.
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I have had a stroke.
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I am living with HIV/AIDS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 214 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~214 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo
Secondary study objectives
Change in CSF Amyloid-β compared to placebo
Change in CSF p-tau compared to placebo
Change in CSF tau compared to placebo
+8 moreSide effects data
From 2018 Phase 4 trial • 12 Patients • NCT033125178%
Dizziness
8%
Upset
8%
Anxiety
8%
Dry Mouth
8%
Tingling sensation in arm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Belsomra 20mg
Belsomra 10mg
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
1,988 Previous Clinical Trials
2,295,434 Total Patients Enrolled
Good Ventures FoundationUNKNOWN
Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,238 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.
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