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

• Status: Completed
• Trial end date: 2019-11-19
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase 2, randomized, placebo controlled, dose ranging study of piromelatine (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on efficacy (cognitive performance), safety and tolerability in patients with mild dementia due to AD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurim Pharmaceuticals Ltd.

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 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).