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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.