Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
NCT ID: NCT02576639
Last Updated: 2017-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2015-08-10
2016-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
Placebo
Matching placebo to CNP520 was supplied in capsules.
CNP520 2 mg
CNP520 2 mg was taken qd orally for 13 weeks.
CNP520
CNP520 10 mg
CNP520 10 mg was taken qd orally for 13 weeks.
CNP520
CNP520 35 mg
CNP520 35 mg was taken qd orally for 13 weeks.
CNP520
CNP520 85 mg
CNP520 85 mg was taken qd orally for 13 weeks.
CNP520
Interventions
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CNP520
Placebo
Matching placebo to CNP520 was supplied in capsules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight: ≥45kg
* BMI: 18-34 kg/m2
Exclusion Criteria
* Heavy smoker status
* History /presence of clinically significant neurological or psychiatric disorders
* Any medical condition that might lead to or is associated with any cognitive deficit
* History or presence of severely impaired renal function
60 Years
80 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Glendale, California, United States
Novartis Investigative Site
Long Beach, California, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Lincoln, Nebraska, United States
Novartis Investigative Site
Antwerp, , Belgium
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Groningen, GZ, Netherlands
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
Belfast, Northern Ireland, United Kingdom
Novartis Investigative Site
Harrow, , United Kingdom
Novartis Investigative Site
Mid Glamorgan, , United Kingdom
Countries
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Other Identifiers
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2013-005576-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCNP520X2102
Identifier Type: -
Identifier Source: org_study_id
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