Japanese patients with mild cognitive impairment who has difficulty initiating sleep
Conditions
Sponsors
Motomura Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) A patient aged from 60 to 84 years at the time of obtaining informed consent. (2) A patient who meets diagnostic criteria for mild cognitive impairment in DSM-5. (3) A patient whose usual averaged sleep onset latency (time to falling asleep from bedtime) of 30 minutes or longer continues for 3 months or longer at the time of informed consent. (4) A patient who is able to visit the hospital as scheduled. (5) A patient is an outpatient. (6) A patient who participates in the study voluntarily, and gives written informed consent.
Exclusion criteria
Exclusion criteria: (1) A patient who has a past history to ingest melatonin including its supplements for more than 1 week. (2) A patient who has a past history of hypersensitivity or allergy to melatonin or ramelteon. (3) A patient who has hepatic dysfunction (AST>100 U/L or ALT>100 U/L). (4) A patient who has received prohibited concomitant medications (including OTC drugs or supplements for melatonin) or has started to receive instructions/therapies for improving sleep within 4 weeks prior to the start of the Screening period, or requires those medications or the start of those during the study period. (5) A patient who has started to receive restricted therapies (cognitive behavioral therapy or bright light therapy) within 4 weeks prior to the start of the Screening period, or is scheduled to start such medications or treatments during the study period. (6) A patient who is not able to refrain from ingesting beverage containing caffeine (up to 3 cans/cups a day) and alcoholic beverage (up to around 180 mL of Japanese sake or equivalent a day) (7) A patient who is scheduled to have stay out overnight during the study period. (8) A patient who needs to drive a car or operate dangerous machinery during the study period. (9) A patient who has participated in a clinical study or post marketing clinical study and received the study drug (including placebo) or participated in a clinical study or post marketing clinical study for medical devices within 4 months prior to the start of the Screening period. (10) A patient who has participated in a clinical investigation involving invasive examinations within 4 months prior to the start of the Screening period. (11) A female patient who is presently pregnant or breast-feeding, or willing to be pregnant and not to consent to contraception between the informed consent and completion of the study. (12) A patient who is receiving fluvoxamine maleate or may receive the drug during the study period. (13) A patient who has a significant disease or findings to be inappropriate to participate in the study according to the opinion of the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep onset latency based on actigraphy | — |
Secondary
| Measure | Time frame |
|---|---|
| -Sleep parameters on actigraphy (total sleep time, sleep efficiency, number of arousals and wake time after sleep onset) -Grand total score based on MMSE | — |
Contacts
Public ContactTomoko Motomura
Nobelpharma Co., Ltd.
Outcome results
None listed