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



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:60 - 85
Updated:3/23/2019
Start Date:November 2015
End Date:April 2019

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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.


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).
We found this trial at
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Flowood, Mississippi 39232
Phone: 601-420-5810
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-1821
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
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Amherst, New York
Phone: 716-250-2000
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Baltimore, Maryland 21208
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Bellflower, California 90706
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Brooklyn, New York 11229
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Brooklyn, New York 11235
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Charleston, South Carolina 29401
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Charlotte, North Carolina 28204
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Chesterfield, Missouri 63005
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Coconut Creek, Florida 33066
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-9032
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Coral Gables, Florida 33146
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Farmington Hills, Michigan 48334
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Hattiesburg, Mississippi 39401
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Hialeah, Florida 33012
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Hialeah, Florida 33016
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Jenkintown, Pennsylvania 19046
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Lake Charles, Louisiana 70601
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8550 Marshall Drive
Lenexa, Kansas 66214
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Lewisville, Texas 75067
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Long Beach, California 90807
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Madison, Wisconsin 53715
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Manchester, New Jersey 08759
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Media, Pennsylvania 19063
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Mount Arlington, New Jersey 07856
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Norwalk, Connecticut 06851
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Orange City, Florida 32763
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Orem, Utah 84058
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Pomona, California 91767
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Princeton, New Jersey 08540
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Raleigh, North Carolina 27609
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Redlands, California 92374
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Richland, Washington 99352
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Salt Lake City, Utah 84107
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San Antonio, Texas
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San Diego, California 92103
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750 East Adams Street
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Tampa, Florida 33609
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West Long Branch, New Jersey 07764
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Wichita, Kansas 67214
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3300 Seymour Highway
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