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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

  Show 59 Study Locations
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