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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
Suvorexant 20mg will be taken nightly for 24 months.
Placebo will be taken nightly for 24 months.
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGChange from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo
Blood collection
Time frame: 18-24 months
Change in plasma Amyloid-β compared to placebo
Blood collection
Time frame: 18-24 months
Change in CSF Amyloid-β compared to placebo
Cerebrospinal fluid collection
Time frame: 18-24 months
Change in plasma tau compared to placebo
Blood collection
Time frame: 18-24 months
Change in CSF tau compared to placebo
Cerebrospinal fluid collection
Time frame: 18-24 months
Change in plasma p-tau compared to placebo
Blood collection
Time frame: 18-24 months
Change in CSF p-tau compared to placebo
Cerebrospinal fluid collection
Time frame: 18-24 months
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.
Time frame: 18-24 months
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Change in transcriptomics compared to placebo
blood and optional CSF collection
Time frame: 18-24 months
Change in metabolomics compared to placebo
blood and optional CSF collection
Time frame: 18-24 months
Change in proteomics compared to placebo
blood and optional CSF collection
Time frame: 18-24 months
Change in gut microbiome compared to placebo
optional stool sample collection
Time frame: 18-24 months