Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT02615002
Eligibility Criteria:
Inclusion Criteria:
* Patient and caregiver are willing to take part in the entire study
* Signed informed consent from the patient and the caregiver
* Patient has a documented history either in medical records or from an informant of cognitive decline over at least 6 months
* Patient has mild probable AD as consistent with criteria established by the National Institute on Aging and Alzheimer's Association (NIA-AA).
* CT/MRI scan with finding consisting of probable AD obtained during the last 12 months before Screening
* Patient has an MMSE score of 21-26 (inclusive) at Screening
* Patient has a Clinical Dementia Rating Global Score (CDR-GS) of 0.5-1 (mild dementia) at Screening
* Patients receiving prescribed drugs for treatment of AD including acetyl cholinesterase inhibitors \[eg, donepezil, galantamine, rivastigmine\] should be on a stable dose for at least 3 months before Screening
* Patient has a negative drug screen (benzodiazepines or opiates) at Screening
* Female patients must have had last natural menstruation ≥ 24 months before Screening, OR being surgically sterile
* Male patients must agree to the use of effective contraception if the female partner is of childbearing potential, OR be surgically sterile
Exclusion Criteria:
* Patient has an alternative cause for dementia other than AD as determined by CT or MRI scan
* Patient has evidence of any clinically significant neurodegenerative disease
* Patient has been diagnosed with the following Axis I disorders (DSM V criteria)
* Patient has a history of uncontrolled or untreated cardiovascular, endocrine, gastrointestinal, respiratory, or rheumatologic disorders within the past 5 years
* Patient has severe pain that is likely to interfere with sleep
* Continuous use of benzodiazepines or other sedative-hypnotics during the 2 weeks before Screening
* Use of any kind of melatonin/melatonin agonist during the 2 weeks before Screening
* Patient has known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists
* Patients with an irregular lifestyle or life pattern (eg, shift workers, patients likely to be jet lagged).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT02615002
Study Brief:
Protocol Section:
NCT02615002