Sleep Trial to Prevent Alzheimer's Disease

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Suvorexant

Criteria

Inclusion Criteria:

• Male or female.

• Any race or ethnicity.

• Participants must be age ≥65 years and able to sign informed consent.

• PET PIB standard uptake value ratio (SUVR) between >1.42 to <3.

• Clinical Dementia Rating (CDR) 0.

• Willing and able to undergo study procedures.

• Capacity to give informed consent and follow study procedures.

Exclusion Criteria:

• Any sleep disorders other than insomnia, such as history or reported symptoms suggestive of restless legs syndrome, narcolepsy, parasomnia, or other sleep disorders.

• Actigraphic sleep efficiency ≥85%.

• Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways).

• No history of sleep-disordered breathing and STOP-Bang score > 3.

• AHI >15.

• Stroke.

• History of hepatic or renal impairment.

• 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

• 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 (e.g. participants with severe chronic back pain might not be able to lie still during the scanning procedures). 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.

• Abnormal safety labs

• History of current suicidal ideations.

• Contraindications to PET, CT, or MRI (e.g. electronic medical devices, inability to lie still for extended periods) that make it unsafe for the individual to participate.

• Retained metal in any body part included implanted medical devices or metal near the orbit or skull.

• All participants will be screened and excluded for neurologic or psychiatric co-morbidities that could affect cognition as well as medical co-morbidities that may prevent participants from undergoing PET/MRI, or cause excessive motion during scanning.

• Has hypersensitivity to AV-1451 and PIB or any of its excipients.

• Severe claustrophobia.

• Currently pregnant or breast-feeding. Women must agree to avoid becoming pregnant and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Flortaucipir injection.

• 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.

• Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1.

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).