NEUP11-AD2: Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging Study of Piromelatine in Patients With Mild Dementia due to Alzheimer’s Disease

Investigator: Elizabeth Crocco

Institutional Protocol #: 20150961

National Clinical Trials Identifier: NCT02615002

Funding Agency/Sponsor: Neurim Pharmaceuticals AG

Division: Psychiatry

Therapeutic Area: Other

Phase: Phase II

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 11/4/2016


Purpose/Abstract:


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.




Eligibility Criteria:


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).


Gender: All

Minimum Age: 60 Years

Maximum Age: 85 Years

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Belinda Robertson, Clinical Research Coordinator
(305) 243 2891
b.ryan1@miami.edu

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