Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age

NCT ID: NCT02576639

Last Updated: 2017-08-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-10

Study Completion Date

2016-03-11

Brief Summary

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The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo to CNP520 was supplied in capsules.

CNP520 2 mg

CNP520 2 mg was taken qd orally for 13 weeks.

Group Type EXPERIMENTAL

CNP520

Intervention Type DRUG

CNP520 10 mg

CNP520 10 mg was taken qd orally for 13 weeks.

Group Type EXPERIMENTAL

CNP520

Intervention Type DRUG

CNP520 35 mg

CNP520 35 mg was taken qd orally for 13 weeks.

Group Type EXPERIMENTAL

CNP520

Intervention Type DRUG

CNP520 85 mg

CNP520 85 mg was taken qd orally for 13 weeks.

Group Type EXPERIMENTAL

CNP520

Intervention Type DRUG

Interventions

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CNP520

Intervention Type DRUG

Placebo

Matching placebo to CNP520 was supplied in capsules.

Intervention Type DRUG

Other Intervention Names

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CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.

Eligibility Criteria

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Inclusion Criteria

* Healthy status
* Body weight: ≥45kg
* BMI: 18-34 kg/m2

Exclusion Criteria

* History or presence of any clinically significant disease of any major system organ class.
* 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Novartis Investigative Site

Long Beach, California, United States

Site Status

Novartis Investigative Site

Miami, Florida, United States

Site Status

Novartis Investigative Site

Lincoln, Nebraska, United States

Site Status

Novartis Investigative Site

Antwerp, , Belgium

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Groningen, GZ, Netherlands

Site Status

Novartis Investigative Site

Leiden, , Netherlands

Site Status

Novartis Investigative Site

Belfast, Northern Ireland, United Kingdom

Site Status

Novartis Investigative Site

Harrow, , United Kingdom

Site Status

Novartis Investigative Site

Mid Glamorgan, , United Kingdom

Site Status

Countries

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United States Belgium Germany Netherlands United Kingdom

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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