Sleep Trial to Prevent Alzheimer's Disease

Alzheimer Disease Clinical Trial

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Official title:

Sleep Trial to Prevent Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04629547
• Other study ID #: 2020008007
• Status: Recruiting
• Phase: Phase 2
• Start date: May 25, 2022
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Cristina Toedebusch, BS
• Phone: 3147470646
• Email: toedebuschc[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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
• Actigraphic sleep efficiency =85%.
• Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways).
• STOP-Bang score = 5 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% =0.82
• Stroke.
• Chronic kidney disease defined as patients with markers of kidney damage or eGFR of < 60 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.
• Body mass index >35.
• History of substance abuse or alcoholism in the proceeding 6 months.
• History of 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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Sleep

Intervention

Drug:
• Suvorexant 20 mg
Suvorexant 20mg will be taken nightly for 24 months.
• Placebo
Placebo will be taken nightly for 24 months.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Good Ventures Foundation, Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Amyloid-ß accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo	Blood collection	24 months
Secondary	Change in plasma Amyloid-ß compared to placebo	Blood collection	24 months
Secondary	Change in CSF Amyloid-ß compared to placebo	Cerebrospinal fluid collection	24 months
Secondary	Change in plasma tau compared to placebo	Blood collection	24 months
Secondary	Change in CSF tau compared to placebo	Cerebrospinal fluid collection	24 months
Secondary	Change in plasma p-tau compared to placebo	Blood collection	24 months
Secondary	Change in CSF p-tau compared to placebo	Cerebrospinal fluid collection	24 months
Secondary	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.	24 months
Secondary	Change in transcriptomics compared to placebo	blood and optional CSF collection	24 months
Secondary	Change in metabolomics compared to placebo	blood and optional CSF collection	24 months
Secondary	Change in proteomics compared to placebo	blood and optional CSF collection	24 months
Secondary	Change in gut microbiome compared to placebo	optional stool sample collection	214 months