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

Sponsor
Neurim Pharmaceuticals Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02615002
Collaborator
(none)
500
Enrollment
56
Locations
4
Arms
48.6
Duration (Months)
8.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2015
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Nov 19, 2019

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Computerized neuropsychological test battery (cNTB) [26 weeks]

    Secondary Outcome Measures

    1. Change from baseline in Global Impression of Change (CGIC) [26 weeks]

    2. Change from baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS-MCI-ADL) [4, 13, 26 weeks]

    3. Change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog14) [13, 26 weeks]

    4. Safety and tolerability of piromelatine [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 [26 weeks]

    2. Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [4, 13, 26 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 Territory Neurology & Research Institute Tucson Arizona United States 85704
    3 Citrials Inc Bellflower California United States 90706
    4 Alliance for Research Long Beach California United States 90807
    5 Renew Behavioral Health, Inc Long Beach California United States 90807
    6 ABS Health LLC Pomona California United States 91767
    7 Anderson Clinical Research Redlands California United States 92374
    8 Pacific Research Network, Inc San Diego California United States 92103
    9 Sharp Mesa Vista Clinical research San Diego California United States 92123
    10 Syrentis Clinical Research Santa Ana California United States 92705
    11 Research Center For Clinical Studies, Inc Norwalk Connecticut United States 06851
    12 Pioneer Clinical research Coconut Creek Florida United States 33066
    13 University of Miami Coral Gables Florida United States 33146
    14 MD Clinical Hallandale Beach Florida United States 33009
    15 New Life Medical Research Center Hialeah Florida United States 33012
    16 Galiz reserach Hialeah Florida United States 33016
    17 Biomed Research Institute Miami Florida United States 33126
    18 Miami Jewish Health Systems Miami Florida United States 33137
    19 Advanced Clinical research Network Miami Florida United States 33176
    20 Medical Research Group of central Florida Inc. Orange City Florida United States 32763
    21 The Roskamp Institute, Inc Sarasota Florida United States 34243
    22 Infinity Clinical Research, LLC. Sunrise Florida United States 33351
    23 Olympian Clinical Research Tampa Florida United States 33609
    24 Rowe Neurology Lenexa Kansas United States 66214
    25 KU School of Medicine-Wichita Wichita Kansas United States 67214
    26 Lake Charles Clinical Trials, LLC Lake Charles Louisiana United States 27604
    27 Pharmasite Research INC Baltimore Maryland United States 21208
    28 Quest Research Institute Farmington Hills Michigan United States 48334
    29 Precise Research Centers Flowood Mississippi United States 39232
    30 Hattiesburg Clinic, P.A. Hattiesburg Mississippi United States 39401
    31 Galen Research Chesterfield Missouri United States 63005
    32 Alzheimer's Research Corporation Manchester New Jersey United States 08759
    33 The Neurocognitive Institute, LLC Mount Arlington New Jersey United States 07856
    34 Global Medical Institutes Princeton New Jersey United States 08540
    35 Neurology Specialists of Monmouth County West Long Branch New Jersey United States 07764
    36 Dent Neurosciences Research Center, Inc Amherst New York United States 14226
    37 Integrative Clinical Trials, LLC Brooklyn New York United States 11229
    38 SPRI Clinical Trials, LLC Brooklyn New York United States 11235
    39 Manhattan Behavioral Medicine, PLLC New York New York United States 10022
    40 Richmond Behavioral Associates Staten Island New York United States 10312
    41 SUNY Upstate Medical University Syracuse New York United States 13210
    42 New Hope Clinical research Charlotte North Carolina United States 28211
    43 Richard H. Weisler, M.D., P.A. & Associates Raleigh North Carolina United States 27609
    44 The Ohio State University Columbus Ohio United States 43221
    45 Red river medical research Center Oklahoma City Oklahoma United States 73112
    46 Tulsa Clinical Research, LLC. Tulsa Oklahoma United States 74104
    47 The Clinical research Center LLC Jenkintown Pennsylvania United States 19046
    48 Suburban Research Associates Media Pennsylvania United States 19063
    49 Roper St. Francis Healthcare Charleston South Carolina United States 29401
    50 Shepherd Clinical Research LLC Lewisville Texas United States 75067
    51 Radiant Research San Antonio Texas United States 78229
    52 Grayline Research Center Wichita Falls Texas United States 76309
    53 Aspen Clinical research Orem Utah United States 84058
    54 Wasatch Clinical Research LLC Salt Lake City Utah United States 84107
    55 Zain Research, Llc Richland Washington United States 99352
    56 SSM Health/Dean Medical Group Madison Wisconsin United States 53715

    Sponsors and Collaborators

    • Neurim Pharmaceuticals Ltd.

    Investigators

    • Study Chair: Lon Schneider, MD, Keck School of Medicine of USC, Los Angeles, CA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Neurim Pharmaceuticals Ltd.
    ClinicalTrials.gov Identifier:
    NCT02615002
    Other Study ID Numbers:
    • NeuP11-AD2
    First Posted:
    Nov 25, 2015
    Last Update Posted:
    Feb 26, 2020
    Last Verified:
    Aug 1, 2019
    Keywords provided by Neurim Pharmaceuticals Ltd.
    Cognition
    mild Alzheimer's disease
    Sleep
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Feb 26, 2020