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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02615002
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : April 11, 2018
Information provided by (Responsible Party):
Neurim Pharmaceuticals Ltd.

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 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
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

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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

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).

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 identifier (NCT number): NCT02615002

Contact: Neurim Pharmaceuticals, Ltd. 972-3-7684965

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact    205-934-1821   
United States, Arizona
Territory Neurology & Research Institute Recruiting
Tucson, Arizona, United States, 85704
Contact    520-742-1833   
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Citrials Inc Recruiting
Bellflower, California, United States, 90706
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Alliance for Research Recruiting
Long Beach, California, United States, 90807
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Renew Behavioral Health, Inc Recruiting
Long Beach, California, United States, 90807
Contact    562-426-3300      
ABS Health LLC Recruiting
Pomona, California, United States, 91767
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Anderson Clinical Research Recruiting
Redlands, California, United States, 92374
Contact    909-792-9007   
Pacific Research Network, Inc Recruiting
San Diego, California, United States, 92103
Contact    619-294-4302      
Sharp Mesa Vista Clinical research Recruiting
San Diego, California, United States, 92123
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Syrentis Clinical Research Recruiting
Santa Ana, California, United States, 92705
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Shreenath Clinical Service Withdrawn
Yorba Linda, California, United States, 92886
United States, Connecticut
Research Center For Clinical Studies, Inc Recruiting
Norwalk, Connecticut, United States, 06851
Contact    203-838-0070      
United States, Florida
Meridien Research INC Recruiting
Brooksville, Florida, United States, 34601
Contact    352-597-8839      
Pioneer Clinical research Recruiting
Coconut Creek, Florida, United States, 33066
Contact: Nilay Mehta    954-204-0052   
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Contact    305-355-8186      
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
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New Life Medical Research Center Recruiting
Hialeah, Florida, United States, 33012
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Hialeah, Florida, United States, 33016
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Biomed Research Institute Recruiting
Miami, Florida, United States, 33126
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Miami Jewish Health Systems Recruiting
Miami, Florida, United States, 33137
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Advanced Clinical research Network Recruiting
Miami, Florida, United States, 33176
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Medical Research Group of central Florida Inc. Recruiting
Orange City, Florida, United States, 32763
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The Roskamp Institute, Inc Recruiting
Sarasota, Florida, United States, 34243
Contact    941-752-2949   
Infinity Clinical Research, LLC. Recruiting
Sunrise, Florida, United States, 33351
Contact    954-366-0277      
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Tampa, Florida, United States, 33609
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United States, Kansas
Rowe Neurology Recruiting
Lenexa, Kansas, United States, 66214
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KU School of Medicine-Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact    316-293-3805   
United States, Louisiana
Lake Charles Clinical Trials, LLC Recruiting
Lake Charles, Louisiana, United States, 27604
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United States, Maryland
Pharmasite Research INC Recruiting
Baltimore, Maryland, United States, 21208
Contact    410-602-1440      
United States, Michigan
Quest Research Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact    248-957-8940      
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Precise Research Centers Recruiting
Flowood, Mississippi, United States, 39232
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Hattiesburg Clinic, P.A. Recruiting
Hattiesburg, Mississippi, United States, 39401
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United States, Missouri
Galen Research Recruiting
Chesterfield, Missouri, United States, 63005
Contact    314-546-5888      
United States, New Jersey
Alzheimer's Research Corporation Recruiting
Manchester, New Jersey, United States, 08759
Contact    732-657-6100      
The Neurocognitive Institute, LLC Recruiting
Mount Arlington, New Jersey, United States, 07856
Contact    888-740-7517   
Global Medical Institutes Recruiting
Princeton, New Jersey, United States, 08540
Contact    718-339-7711   
Neurology Specialists of Monmouth County Recruiting
West Long Branch, New Jersey, United States, 07764
Contact    732-935-1850   
United States, New York
Dent Neurosciences Research Center, Inc Recruiting
Amherst, New York, United States, 14226
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Integrative Clinical Trials, LLC Recruiting
Brooklyn, New York, United States, 11229
Contact    718-444-7774   
SPRI Clinical Trials, LLC Recruiting
Brooklyn, New York, United States, 11235
Contact    718-616-2400      
Manhattan Behavioral Medicine, PLLC Recruiting
New York, New York, United States, 10022
Contact    646-678-4196   
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10312
Contact    718-317-5522      
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact    315-464-9756   
United States, North Carolina
New Hope Clinical research Recruiting
Charlotte, North Carolina, United States, 28211
Contact    980-209-9784      
Richard H. Weisler, M.D., P.A. & Associates Recruiting
Raleigh, North Carolina, United States, 27609
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Wake Research Associates, Llc Recruiting
Raleigh, North Carolina, United States, 27612
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The Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact    614-293-9032   
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Red river medical research Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
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Tulsa, Oklahoma, United States, 74104
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The Clinical research Center LLC Recruiting
Jenkintown, Pennsylvania, United States, 19046
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Suburban Research Associates Recruiting
Media, Pennsylvania, United States, 19063
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Roper St. Francis Healthcare Recruiting
Charleston, South Carolina, United States, 29401
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Shepherd Clinical Research LLC Recruiting
Lewisville, Texas, United States, 75067
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Radiant Research Recruiting
San Antonio, Texas, United States, 78229
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Grayline Research Center Recruiting
Wichita Falls, Texas, United States, 76309
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Aspen Clinical research Recruiting
Orem, Utah, United States, 84058
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Wasatch Clinical Research LLC Recruiting
Salt Lake City, Utah, United States, 84107
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United States, Washington
Zain Research, Llc Suspended
Richland, Washington, United States, 99352
United States, Wisconsin
SSM Health/Dean Medical Group Recruiting
Madison, Wisconsin, United States, 53715
Contact    608-283-7316      
Sponsors and Collaborators
Neurim Pharmaceuticals Ltd.
Study Chair: Lon Schneider, MD Keck School of Medicine of USC, Los Angeles, CA

Study Data/Documents: Study website  This link exits the site

Responsible Party: Neurim Pharmaceuticals Ltd. Identifier: NCT02615002     History of Changes
Other Study ID Numbers: NeuP11-AD2
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Neurim Pharmaceuticals Ltd.:
mild Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders