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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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 Alzheimer's Disease (AD).

Key facts

Study ID

NCT02615002

Run by

Neurim Pharmaceuticals Ltd.

People needed

371

Starts

2015-11-01

Expected to finish

2019-11-19

Last updated by the study team

2024-07-05

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient and caregiver are willing to take part in the entire study
• Signed informed consent from the patient and the caregiver
• Patient has a 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 National Institute on Aging and Alzheimer's Association (NIA-AA).
• CT/MRI scan with finding consisting of 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 being surgically sterile
• Male patients must agree to the use of effective contraception if the female partner is of childbearing potential, OR be surgically sterile

You may not qualify if…

• 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).

Where it is running

• Territory Neurology & Research Institute — Tucson, Arizona, United States
• Citrials Inc — Bellflower, California, United States
• Alliance for Research — Long Beach, California, United States
• Renew Behavioral Health, Inc — Long Beach, California, United States
• ABS Health LLC — Pomona, California, United States
• Anderson Clinical Research — Redlands, California, 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
• Research Center For Clinical Studies, Inc — Norwalk, Connecticut, United States
• Pioneer Clinical research — Coconut Creek, Florida, United States
• University of Miami — Coral Gables, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• New Life Medical Research Center — Hialeah, Florida, United States
• Galiz reserach — Hialeah, Florida, United States
• Biomed Research Institute — Miami, Florida, United States
• Miami Jewish Health Systems — Miami, Florida, United States
• Advanced Clinical research Network — Miami, Florida, United States
• Medical Research Group of central Florida Inc. — Orange City, Florida, United States
• The Roskamp Institute, Inc — Sarasota, Florida, United States
• Infinity Clinical Research, LLC. — Sunrise, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Rowe Neurology — Lenexa, Kansas, United States
• KU School of Medicine-Wichita — Wichita, Kansas, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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