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

This study is currently recruiting participants.
Verified November 2017 by Neurim Pharmaceuticals Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02615002
First Posted: November 25, 2015
Last Update Posted: December 1, 2017
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.
Information provided by (Responsible Party):
Neurim Pharmaceuticals Ltd.
November 18, 2015
November 25, 2015
December 1, 2017
November 2015
March 2018   (Final data collection date for primary outcome measure)
Change from baseline in Computerized neuropsychological test battery (cNTB) [ Time Frame: 26 weeks ]
Same as current
Complete list of historical versions of study NCT02615002 on ClinicalTrials.gov Archive Site
  • Change from baseline in Global Impression of Change (CGIC) [ Time Frame: 26 weeks ]
  • 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 ]
  • Change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog14) [ Time Frame: 13, 26 weeks ]
  • 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.
  • Chnage from baseline in Global Impression of Change (CGIC) [ Time Frame: 26 weeks ]
  • 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 ]
  • Change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog14) [ Time Frame: 13, 26 weeks ]
  • 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.
  • Change form baseline in Neuropsychiatric Inventory (NPI) scale [ Time Frame: 26 weeks ]
  • Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 4, 13, 26 weeks ]
  • Change form baseline in Neuropsychiatric Inventory (NPI) scale [ Time Frame: 26 weeks ]
  • Change from baseline in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 4,13, 26 weeks ]
 
Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)
Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of Piromelatine in Patients With Mild Dementia Due to Alzheimer's Disease
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Piromelatine
    Other Name: Neu-P11
  • Drug: Placebo
  • Experimental: piromelatine 5 mg
    5 mg tablets once daily
    Intervention: Drug: Piromelatine
  • Experimental: piromelatine 20 mg
    20 mg tablets once daily
    Intervention: Drug: Piromelatine
  • Experimental: piromelatine 50 mg
    50 mg tablets once daily
    Intervention: Drug: Piromelatine
  • Placebo Comparator: Placebo
    Placebo tablet once daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2018
March 2018   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
60 Years to 85 Years   (Adult, Senior)
No
Contact: Neurim Pharmaceuticals, Ltd. 972-3-7684965 recognition@neurim.com
United States
 
 
NCT02615002
NeuP11-AD2
Yes
Not Provided
Not Provided
Neurim Pharmaceuticals Ltd.
Neurim Pharmaceuticals Ltd.
Not Provided
Study Chair: Lon Schneider, MD Keck School of Medicine of USC, Los Angeles, CA
Neurim Pharmaceuticals Ltd.
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP