A randomized, double-blind, placebo controlled, four-period, cross-over study to evaluate the cognitive effects of single oral administration of roflumilast in age-associated memory impairment

Takeda Pharma A/S0 sites80 target enrollmentMay 23, 2017

ConditionsDementia Mental and Behavioural Disorders

Overview

Phase: 未知
Intervention: Not specified
Conditions: Dementia
Sponsor: Takeda Pharma A/S
Enrollment: 80
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2019 results in: https://doi.org/10.1016/j.neurobiolaging.2019.01.014

Registry

who.int

Start Date

May 23, 2017

End Date

July 1, 2015

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Takeda Pharma A/S

Eligibility Criteria

Inclusion Criteria

•1\. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements
•2\. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
•3\. Healthy adult as judged by Medical Supervisor
•4\. Aged 60 to 80 years, inclusive, at the time of informed consent
•5\. Memory performance between 1 to 2 SD below (for Impaired Elderly) and between 0\.5 SD below and 0\.5 SD above (for Healthy Elderly) age, gender, and education level corrected normative values assessed using the VLT
•6\. The subject has normal hearing demonstrated by average audiometric hearing thresholds of 20 dB hearing level (HL) and relatively symmetric hearing (left/right ear asymmetry of 15 dB)
•7\. Body mass index (BMI) between 18 and 30 kg/m2 inclusive at Screening
•8\. A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose
•9\. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use acceptable methods of contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose
•10\. Clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) within the reference range for the testing laboratory, unless the results are deemed not to be clinically significant (CS) by the investigator or sponsor at screening and Day 1 of Period 1

Exclusion Criteria

•1\. Received any investigational compound within 30 days prior to the first dose of study medication
•2\. Received roflumilast in a previous clinical study or as a therapeutic agent
•3\. Immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress
•4\. Uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results
•5\. Previous or existing major psychiatric symptoms (evaluated through semi\- Structured Clinical Interview for DSM MINI for the assessment of lifetime DSM\-IV Axis \-II diagnoses)
•6\. Known hypersensitivity to any component of the formulation of roflumilast or related compounds
•7\. Positive urine drug result for drugs of abuse at Screening Visit 2
•8\. History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the screening visit or is unwilling to agree to abstain from alcohol from 72 hrs prior to Day 1 through Day 2 of each Period and/or drugs throughout the study
•9\. Taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table listed in Section 7\.3
•10\. Evidence of uncontrolled cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the subject’s medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking roflumilast or a similar drug in the same class, or that might interfere with the conduct of the study as judged by Medical Supervisor. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.