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

Alzheimer's Disease Clinical Trial

Official title:

Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of Piromelatine in Patients With Mild Dementia Due to Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615002
• Other study ID #: NeuP11-AD2
• Status: Completed
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: November 19, 2019

Study information

• Verified date: August 2019
• Source: Neurim Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 19, 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Piromelatine

• Placebo

Locations

Country	Name	City	State
United States	Dent Neurosciences Research Center, Inc	Amherst	New York
United States	Pharmasite Research INC	Baltimore	Maryland
United States	Citrials Inc	Bellflower	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Integrative Clinical Trials, LLC	Brooklyn	New York
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Roper St. Francis Healthcare	Charleston	South Carolina
United States	New Hope Clinical research	Charlotte	North Carolina
United States	Galen Research	Chesterfield	Missouri
United States	Pioneer Clinical research	Coconut Creek	Florida
United States	The Ohio State University	Columbus	Ohio
United States	University of Miami	Coral Gables	Florida
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Precise Research Centers	Flowood	Mississippi
United States	MD Clinical	Hallandale Beach	Florida
United States	Hattiesburg Clinic, P.A.	Hattiesburg	Mississippi
United States	Galiz reserach	Hialeah	Florida
United States	New Life Medical Research Center	Hialeah	Florida
United States	The Clinical research Center LLC	Jenkintown	Pennsylvania
United States	Lake Charles Clinical Trials, LLC	Lake Charles	Louisiana
United States	Rowe Neurology	Lenexa	Kansas
United States	Shepherd Clinical Research LLC	Lewisville	Texas
United States	Alliance for Research	Long Beach	California
United States	Renew Behavioral Health, Inc	Long Beach	California
United States	SSM Health/Dean Medical Group	Madison	Wisconsin
United States	Alzheimer's Research Corporation	Manchester	New Jersey
United States	Suburban Research Associates	Media	Pennsylvania
United States	Advanced Clinical research Network	Miami	Florida
United States	Biomed Research Institute	Miami	Florida
United States	Miami Jewish Health Systems	Miami	Florida
United States	The Neurocognitive Institute, LLC	Mount Arlington	New Jersey
United States	Manhattan Behavioral Medicine, PLLC	New York	New York
United States	Research Center For Clinical Studies, Inc	Norwalk	Connecticut
United States	Red river medical research Center	Oklahoma City	Oklahoma
United States	Medical Research Group of central Florida Inc.	Orange City	Florida
United States	Aspen Clinical research	Orem	Utah
United States	ABS Health LLC	Pomona	California
United States	Global Medical Institutes	Princeton	New Jersey
United States	Richard H. Weisler, M.D., P.A. & Associates	Raleigh	North Carolina
United States	Anderson Clinical Research	Redlands	California
United States	Zain Research, Llc	Richland	Washington
United States	Wasatch Clinical Research LLC	Salt Lake City	Utah
United States	Radiant Research	San Antonio	Texas
United States	Pacific Research Network, Inc	San Diego	California
United States	Sharp Mesa Vista Clinical research	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	The Roskamp Institute, Inc	Sarasota	Florida
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Infinity Clinical Research, LLC.	Sunrise	Florida
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Olympian Clinical Research	Tampa	Florida
United States	Territory Neurology & Research Institute	Tucson	Arizona
United States	Tulsa Clinical Research, LLC.	Tulsa	Oklahoma
United States	Neurology Specialists of Monmouth County	West Long Branch	New Jersey
United States	KU School of Medicine-Wichita	Wichita	Kansas
United States	Grayline Research Center	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Neurim Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change form baseline in Neuropsychiatric Inventory (NPI) scale		26 weeks
Other	Change from baseline in Pittsburgh Sleep Quality Index (PSQI)		4, 13, 26 weeks
Primary	Change from baseline in Computerized neuropsychological test battery (cNTB)		26 weeks
Secondary	Change from baseline in Global Impression of Change (CGIC)		26 weeks
Secondary	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
Secondary	Change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog14)		13, 26 weeks
Secondary	Safety and tolerability of piromelatine	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.	26 weeks