Prevention of Alzheimers disease in participants without Alzheimers disease dementia, experiencing sleep problems or not Mental and Behavioural Disorders
Conditions
Interventions
240 participants will be randomized (1:1). There are 2 arms. One experimental arm (daridorexant 50 mg) and one placebo arm. Study drug (daridorexant 50 mg or placebo) will be taken orally each night 3
Sponsors
Douglas Mental Health University Institute
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Without dementia as determined by: MoCA >21 or MMSE > 24 or Clinical Dementia Rating <1 2. Minimum of 6 years of formal education 3. Stable psychoactive medication for 1 month prior to screening with no intention to change dose during treatment period 4. Capacity to provide written consent in English or French
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of major neurocognitive disorder 2. Unstable psychiatric condition 3. Clinically significant active suicidal ideations 4. Unstable medical condition in the opinion of the investigator. 5. Known or suspected history of drug or alcohol dependence or abuse within one year of the screening visit 6. Currently taking a DORA 7. Allergy or significant adverse reaction to DORA 8. Use of benzodiazepines or z-drugs > 2 times per week in the last month. 9. Use of major and moderate CYP3A4 inducers and inhibitors 10. Use of strong central nervous system depressants, opioids, strong analgesics, antipsychotics, sedative antidepressants. 11. Active use of cholinesterase inhibitors or memantine 12. Women who are breast feeding or pregnant 13. Severe obstructive sleep apnea (OSA) 14.Clinically significant non-treated rapid eye movement (REM) sleep behavior disorder, restless leg syndrome or parasomnia; 15. Diagnosis of narcolepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biological progression as measured by p-tau217/np-tau217 ratio in plasma. Time Frame: baseline up to estimated 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biological progression as measured by p-tau181/np-tau181 ratio in plasma. Time Frame: baseline up to estimated 12 months 2. Biological progression as measure by Aß42/Aß40 ratio in plasma. Time Frame: baseline up to estimated 12 months 3. Cognitive progression as measured with a modified version of the Preclinical Alzheimer Cognitive Composite Score. Time Frame: baseline up to estimated 12 months 4. Cognitive progression as measured with the XpressO MoCA medical screening tool. Time Frame: baseline up to estimated 12 months 5. Aß42/Aß40 ratio in cerebrospinal fluid in a subset of participants. Time Frame: baseline up to estimated 12 months 6. Sleep efficiency as measured by EEG recordings. Time Frame: baseline up to estimated 12 months. 7. Astroglial activation and astrocytosis as measured by glial fibrillary acidic protein (GFAP) levels in plasma. Time Frame: baseline up to estimated 12 months. 8. Biological progression as measured by p-tau181/np-tau181 ratio at 3 months, in plasma. Time Frame: baseline to estimated 3 months 9. Biological progression as measured by p-tau217/np-tau217 ratio at 3 months, in plasma. Time Frame: baseline to estimated 3 months | — |
Countries
Canada
Contacts
Public ContactJennifer Tremblay-Mercier
Outcome results
None listed