Clinical trial NCT02576639: Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of CNP520 in Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease,
Amyloid Beta,
cerebrospinal fluid,
beta secretase
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 124
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

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

Key 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

Primary outcomes:
measure: Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
timeFrame: 13 weeks
Secondary outcomes:
measure: Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
timeFrame: Day 92
measure: Summary of Plasma PK Parameter: Cmax
timeFrame: Days 1, 91
measure: Summary of Plasma PK Parameter: AUCtau
timeFrame: Days 1 and 91
measure: Summary of Plasma PK Parameter: Tmax
timeFrame: Days 1 and 91
measure: Summary of Plasma PK Parameter: Tlag
timeFrame: Days 1 and 91
measure: Summary of Plasma PK Parameter: T1/2
timeFrame: Day 91
measure: Summary of PK Parameter: CLss/F
timeFrame: Day 91
measure: Summary of Plasma PK Parameter: Racc
timeFrame: Day 91
measure: Summary of CSF PK Concentrations
timeFrame: Days 1, 14, 28, 42, 56, 70 and 91
measure: Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)
timeFrame: Day 91
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Day 91
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Novartis Investigative Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
state: GZ
city: Leiden
country: Netherlands
facility: Novartis Investigative Site
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
state: Northern Ireland
city: Harrow
country: United Kingdom
facility: Novartis Investigative Site
city: Mid Glamorgan
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: