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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.
ClinicalTrials.gov Identifier: NCT02615002
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : December 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

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 : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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, Senior)
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

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


Contacts
Contact: Neurim Pharmaceuticals, Ltd. 972-3-7684965 recognition@neurim.com

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Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact    205-934-1821    lcowden@uabmc.edu   
United States, Arizona
Territory Neurology & Research Institute Recruiting
Tucson, Arizona, United States, 85704
Contact    520-742-1833    info@territorynri.com   
United States, California
Citrials Inc Recruiting
Bellflower, California, United States, 90706
Contact    866-478-8391      
Alliance for Research Recruiting
Long Beach, California, United States, 90807
Contact    844-283-3649      
Renew Behavioral Health, Inc Recruiting
Long Beach, California, United States, 90807
Contact    562-426-3300      
ABS Health LLC Recruiting
Pomona, California, United States, 91767
Contact    562-309-4541    info@abs-health.com   
Anderson Clinical Research Recruiting
Redlands, California, United States, 92374
Contact    909-792-9007    info@andersonstudies.com   
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
Contact    858-836-8350      
Syrentis Clinical Research Recruiting
Santa Ana, California, United States, 92705
Contact    714-542-3008    mbarelacrc@gmail.com   
Shreenath Clinical Service Recruiting
Yorba Linda, California, United States, 92886
Contact    714-717-6039      
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    nilaymehta@pioneerclinical.com   
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Contact    305-355-8186      
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Contact    954-455-5757      
New Life Medical Research Center Recruiting
Hialeah, Florida, United States, 33012
Contact    786-360-3750    ocana@newlifemedresearch.com   
Galiz reserach Recruiting
Hialeah, Florida, United States, 33016
Contact    305-805-0921      
Biomed Research Institute Recruiting
Miami, Florida, United States, 33126
Contact    305-267-4123      
Miami Jewish Health Systems Recruiting
Miami, Florida, United States, 33137
Contact    305-514-8710      
Advanced Clinical research Network Recruiting
Miami, Florida, United States, 33176
Contact    305-702-1594      
Medical Research Group of central Florida Inc. Recruiting
Orange City, Florida, United States, 32763
Contact    386-775-7627      
The Roskamp Institute, Inc Recruiting
Sarasota, Florida, United States, 34243
Contact    941-752-2949    info@roskampinstitute.net   
Infinity Clinical Research, LLC. Recruiting
Sunrise, Florida, United States, 33351
Contact    954-366-0277      
Olympian Clinical Research Recruiting
Tampa, Florida, United States, 33609
Contact    813-849-5566      
United States, Kansas
Rowe Neurology Recruiting
Lenexa, Kansas, United States, 66214
Contact    913-827-4214    lkemble@neurokc.com   
KU School of Medicine-Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact    316-293-3805    tsteele5@kumc.edu   
United States, Louisiana
Lake Charles Clinical Trials, LLC Recruiting
Lake Charles, Louisiana, United States, 27604
Contact    337-564-6405    info@lakecharlesclinicaltrials.com   
United States, Maryland
Pharmasite Research INC Recruiting
Baltimore, Maryland, United States, 21208
Contact    410-602-1440      
United States, Massachusetts
Activmed Practices & Research INC. Recruiting
Methuen, Massachusetts, United States, 01844
Contact    978-655-7155      
Activmed Practices & Research, Inc Recruiting
Methuen, Massachusetts, United States, 01844
Contact    978-655-7155    info@activmedresearch.com   
United States, Michigan
Quest Research Institute Recruiting
Farmington Hills, Michigan, United States, 48334
Contact    248-957-8940      
United States, Mississippi
Precise Research Centers Recruiting
Flowood, Mississippi, United States, 39232
Contact    601-420-5810      
Hattiesburg Clinic, P.A. Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact    601-264-6000      
United States, Missouri
Galen Research Recruiting
Chesterfield, Missouri, United States, 63005
Contact    314-546-5888      
United States, New Hampshire
Activmed Practices and Research Recruiting
Portsmouth, New Hampshire, United States, 03801
Contact    603-319-8863      
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    info@neuroci.com   
Global Medical Institutes Recruiting
Princeton, New Jersey, United States, 08540
Contact    718-339-7711    Contact@gminstitutes.com   
Neurology Specialists of Monmouth County Recruiting
West Long Branch, New Jersey, United States, 07764
Contact    732-935-1850    avtuvy@neurologyspecialists.org   
United States, New York
Dent Neurosciences Research Center, Inc Recruiting
Amherst, New York, United States, 14226
Contact    716-250-2000      
Integrative Clinical Trials, LLC Recruiting
Brooklyn, New York, United States, 11229
Contact    718-444-7774    info@iclinicaltrials.net   
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    Info@ManhattanBehavioralMedicine.com   
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    hartweal@upstate.edu   
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
Contact    919-872-5900      
Wake Research Associates, Llc Recruiting
Raleigh, North Carolina, United States, 27612
Contact    919-781-2514    contactus@wakeresearch.com   
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact    614-293-9032    Brooke.Eiginger@osumc.edu   
United States, Oklahoma
Red river medical research Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact    405-759-5600    awhite@redriverokc.com   
Tulsa Clinical Research, LLC. Recruiting
Tulsa, Oklahoma, United States, 74104
Contact    918-743-2349    manager@tulsaclinicalresearch.com   
United States, Pennsylvania
The Clinical research Center LLC Recruiting
Jenkintown, Pennsylvania, United States, 19046
Contact    215-884-1700      
Suburban Research Associates Recruiting
Media, Pennsylvania, United States, 19063
Contact    610-891-7200      
United States, South Carolina
Roper St. Francis Healthcare Recruiting
Charleston, South Carolina, United States, 29401
Contact    843-724-2208    Arthur.Williams@rsfh.com   
United States, Texas
Shepherd Clinical Research LLC Recruiting
Lewisville, Texas, United States, 75067
Contact    972-420-8777    support@shepherdhealth.com   
Radiant Research Recruiting
San Antonio, Texas, United States, 78229
Contact    210-614-7843 ext 4210    terifielder@radiantresearch.com   
Greyline Research Center Recruiting
Wichita Falls, Texas, United States, 76309
Contact    940-322-1131    info@graylinecdt.com   
United States, Utah
Aspen Clinical research Recruiting
Orem, Utah, United States, 84058
Contact    801-356-5555      
Wasatch Clinical Research LLC Recruiting
Salt Lake City, Utah, United States, 84107
Contact    801-228-0607      
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.
Investigators
Study Chair: Lon Schneider, MD Keck School of Medicine of USC, Los Angeles, CA
More Information

Study Data/Documents: Study website  This link exits the ClinicalTrials.gov site

Responsible Party: Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT02615002     History of Changes
Other Study ID Numbers: NeuP11-AD2
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: December 1, 2017
Last Verified: November 2017

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

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