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SleepPhase 2SToP-ADNCT04629547

Sleep Trial to Prevent Alzheimer's Disease

A Phase 2 study testing Suvorexant 20 mg in people with Sleep and Alzheimer Disease, run by University of Minnesota at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Sleep, Alzheimer Disease
What is being tested?
Suvorexant 20 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
25 May 2022to May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 28Show fewer
  • 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.
  • -• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cristina Toedebusch, BS contact

3147470646

toedebuschc@wustl.edu

Chloe Meehan, MA contact

3142730878

cmeehan@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Cristina Toedebusch, BS, 314-747-0646, toedebuschc@wustl.edu

    Brendan Lucey, MD

    Recruiting

Other trials in United States

About this study

The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.

Read the detailed description

This study will investigate if long-term treatment with suvorexant will slow amyloid-β accumulation in the brain. Amyloid-β is a protein involved in the disease process leading to Alzheimer's disease. This study will evaluate if suvorexant can decrease the amount of amyloid-beta detected by plasma pT217/T217.

Being tested
Suvorexant 20 mg, Placebo
Keywords
poor sleep, Amyloid-Beta, Insomnia
Medical subject headings
Alzheimer Disease, Plaque, Amyloid, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suvorexant 20 mgDrug

    Also called Belsomra

    Suvorexant 20mg will be taken nightly for 24 months.

  • PlaceboDrug

    Also called inactive pill, sugar pill

    Placebo will be taken nightly for 24 months.

Study groups in NCT04629547
Study groupRoleWhat they receive
Poor sleep treatment groupExperimental60 participants will be randomized to take suvorexant 20mg daily at h.s. for 18-24 months
Receives: Drug: Suvorexant 20 mg
Poor sleep control gropPlacebo comparator60 participants will be randomized to take placebo daily at h.s. for 18-24 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo

    Blood collection

    Measured: 18-24 months

Secondary outcomes (11)

  1. Change in plasma Amyloid-β compared to placebo

    Blood collection

    Measured: 18-24 months

  2. Change in CSF Amyloid-β compared to placebo

    Cerebrospinal fluid collection

    Measured: 18-24 months

  3. Change in plasma tau compared to placebo

    Blood collection

    Measured: 18-24 months

  4. Change in CSF tau compared to placebo

    Cerebrospinal fluid collection

    Measured: 18-24 months

  5. Change in plasma p-tau compared to placebo

    Blood collection

    Measured: 18-24 months

  6. Change in CSF p-tau compared to placebo

    Cerebrospinal fluid collection

    Measured: 18-24 months

  7. Change in cognitive performance compared to placebo

    Measured by a cognitive composite consisting of the Digit Symbol Substitution Test, Animal Naming, Trails B and the Free and Cued Selective Reminding Test. Each test will be z-scored and then averaged together to make the composite.

    Measured: 18-24 months

  8. Change in transcriptomics compared to placebo

    blood and optional CSF collection

    Measured: 18-24 months

  9. Change in metabolomics compared to placebo

    blood and optional CSF collection

    Measured: 18-24 months

  10. Change in proteomics compared to placebo

    blood and optional CSF collection

    Measured: 18-24 months

  11. Change in gut microbiome compared to placebo

    optional stool sample collection

    Measured: 18-24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start25 May 2022
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04629547
Sponsor's protocol ID
202008007
Acronym
SToP-AD
Status last verified
Jul 2026
First submitted
9 Nov 2020
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Noh MY, Kwon HS, Kwon MS, Nahm M, Jin HK, Bae JS, Kim SH. Biomarkers and therapeutic strategies targeting microglia in neurodegenerative diseases: current status and future directions. Mol Neurodegener. 2025 Jul 10;20(1):82. doi: 10.1186/s13024-025-00867-4.

    PubMed 40640892

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Suvorexant 20 mg in people with Sleep and Alzheimer Disease, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cristina Toedebusch, BS (3147470646, toedebuschc@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo (time frame: 18-24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04629547, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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