A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects with Alzheimer’s Disease

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

3

Condition

Insomnia

Treatment

N/A

Clinical Study ID

TX154876
  • Ages 50-90
  • All Genders

Study Summary

This is a study to test the safety and tolerability of the research study drug, suvorexant and test the effects of suvorexant compared to placebo in improving insomnia in subjects with mild to moderate Alzheimer's disease.

Eligibility Criteria

Inclusion

1. Be between 50 to 90 years of age on the day of signing informed consent.
2. Meet the criteria for a diagnosis of probable Alzheimer's disease.
3. Have a Mini Mental State Examination (MMSE) score ≥ 12 and ≤ 26 at Screening.
4. Have a diagnosis of insomnia
5. Be willing to stay overnight at a sleep laboratory and stay in bed for at least 8 hours for PSG testing.
6. Have a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing to maintain it for the duration of the trial.
7. Be able and willing to wear an activity/sleep watch on the wrist throughout the day and night.
8. Each subject (or legal representative) must sign the informed consent form
9. Based on the investigator's judgment (with legal representative input, as applicable),the subject should:* be able to speak, read, and understand the language of the trial staff and the informed consent form; possess the ability to respond verbally to questions, follow instructions, and complete study assessments; be able to adhere to dose and visit schedules.
10. Have a reliable and competent trial partner (e.g., spouse, family member, or other
caregiver)

Study Design

Study Start date:
Estimated Completion Date:

Study Description