Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)

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 clearly 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 NIA-AA

- CT/MRI scan with finding consisted with 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 be surgically sterile

- Male patients must agree to use of effective contraception if 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).