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

Purpose

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.

Condition

  • Alzheimer's Disease

Eligibility

Eligible Ages
Between 60 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
piromelatine 5 mg 		5 mg tablets once daily
  • Drug: Piromelatine
    Other names:
    • Neu-P11
Experimental
piromelatine 20 mg 		20 mg tablets once daily
  • Drug: Piromelatine
    Other names:
    • Neu-P11
Experimental
piromelatine 50 mg 		50 mg tablets once daily
  • Drug: Piromelatine
    Other names:
    • Neu-P11
Placebo Comparator
Placebo 		Placebo tablet once daily
  • Drug: Placebo

More Details

Status
Completed
Sponsor
Neurim Pharmaceuticals Ltd.

Study Contact