NCT02576639

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 25, 2017

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

August 18, 2015

Results QC Date

March 9, 2017

Last Update Submit

August 7, 2017

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease,Amyloid Beta,cerebrospinal fluid,beta secretase

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths

    Safety monitoring was conducted throughout the study.

    13 weeks

Secondary Outcomes (11)

  • Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations

    Day 92

  • Summary of Plasma PK Parameter: Cmax

    Days 1, 91

  • Summary of Plasma PK Parameter: AUCtau

    Days 1 and 91

  • Summary of Plasma PK Parameter: Tmax

    Days 1 and 91

  • Summary of Plasma PK Parameter: Tlag

    Days 1 and 91

  • +6 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

CNP520 2 mg

EXPERIMENTAL

CNP520 2 mg was taken qd orally for 13 weeks.

Drug: CNP520

CNP520 10 mg

EXPERIMENTAL

CNP520 10 mg was taken qd orally for 13 weeks.

Drug: CNP520

CNP520 35 mg

EXPERIMENTAL

CNP520 35 mg was taken qd orally for 13 weeks.

Drug: CNP520

CNP520 85 mg

EXPERIMENTAL

CNP520 85 mg was taken qd orally for 13 weeks.

Drug: CNP520

Interventions

CNP520DRUG
Also known as: CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.
CNP520 10 mgCNP520 2 mgCNP520 35 mgCNP520 85 mg
PlaceboDRUG

Matching placebo to CNP520 was supplied in capsules.

Placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Novartis Investigative Site

Glendale, California, 91206, United States

Location

Novartis Investigative Site

Long Beach, California, 90806, United States

Location

Novartis Investigative Site

Miami, Florida, 33126, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68502, United States

Location

Novartis Investigative Site

Antwerp, 2060, Belgium

Location

Novartis Investigative Site

Berlin, 14050, Germany

Location

Novartis Investigative Site

Groningen, GZ, 9713, Netherlands

Location

Novartis Investigative Site

Leiden, 2333 CL, Netherlands

Location

Novartis Investigative Site

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Location

Novartis Investigative Site

Harrow, HA1 3UJ, United Kingdom

Location

Novartis Investigative Site

Mid Glamorgan, CF484DR, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer DiseasePlaque, Amyloid

Interventions

UmibecestatCapsules

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Study Director

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

October 15, 2015

Study Start

August 10, 2015

Primary Completion

March 11, 2016

Study Completion

March 11, 2016

Last Updated

August 11, 2017

Results First Posted

May 25, 2017

Record last verified: 2017-08

Locations

DE(1)NL(2)BE(1)GB(3)US(4)