Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of Piromelatine in Patients With Mild Dementia Due to Alzheimer's Disease.

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  • sponsor
    Neurim Pharmaceuticals LTD.
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Updated on 8 December 2020
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Summary

Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of Piromelatine in Patients With Mild Dementia Due to Alzheimer's Disease.

Description

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.

All study-related exams, tests, procedures and medication will be provided free of charge. Reasonable compensation for time and travel may be provided.

Details
Clinical Study IdentifierTX145468
SponsorNeurim Pharmaceuticals LTD.
Last Modified on8 December 2020

Eligibility

 Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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