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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02615002
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Neurim Pharmaceuticals Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Piromelatine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of Piromelatine in Patients With Mild Dementia Due to Alzheimer's Disease
Study Start Date : November 2015
Actual Primary Completion Date : June 2019
Actual Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: piromelatine 5 mg
5 mg tablets once daily
 Drug: Piromelatine
Other Name: Neu-P11
Experimental: piromelatine 20 mg
20 mg tablets once daily
 Drug: Piromelatine
Other Name: Neu-P11
Experimental: piromelatine 50 mg
50 mg tablets once daily
 Drug: Piromelatine
Other Name: Neu-P11
Placebo Comparator: Placebo
Placebo tablet once daily
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in Computerized neuropsychological test battery (cNTB) [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Global Impression of Change (CGIC) [ Time Frame: 26 weeks ]
  2. Change from baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS-MCI-ADL) [ Time Frame: 4, 13, 26 weeks ]
  3. Change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog14) [ Time Frame: 13, 26 weeks ]
  4. Safety and tolerability of piromelatine [ Time Frame: 26 weeks ]
    Vital signs measurements (heart rate and blood pressure), reported AEs or SAEs, physical examinations results, clinical laboratory evaluations (hematology, biochemistry, and urinalysis), 12-lead ECGs results and Sheehan Suicidality Tracking Scale scores will be collected throughout the study.


Other Outcome Measures:
  1. Change form baseline in Neuropsychiatric Inventory (NPI) scale [ Time Frame: 26 weeks ]
  2. Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 4, 13, 26 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615002


Locations
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Sponsors and Collaborators
Neurim Pharmaceuticals Ltd.
Investigators
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Study Chair: Lon Schneider, MD Keck School of Medicine of USC, Los Angeles, CA
More Information
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Study Data/Documents: Study website  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT02615002    
Other Study ID Numbers: NeuP11-AD2
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: August 2019
Keywords provided by Neurim Pharmaceuticals Ltd.:
Cognition
mild Alzheimer's disease
Sleep
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders