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A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

NCT02565511 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2021-07-08

Study results available
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Summary

The purpose of this study was to test whether two investigational drugs called CAD106 and CNP520, administered separately, could slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype.

Conditions

  • Alzheimers Disease

Interventions

BIOLOGICAL

CAD106 Immunotherapy

Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.

OTHER

Placebo to CAD106

Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.

DRUG

CNP520

CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.

OTHER

Placebo to CNP520

Placebo to CNP520 p.o. for the duration of the Treatment Epoch

OTHER

Alum

Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106

Sponsors & Collaborators

  • Banner Alzheimer's Institute

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Amgen

    collaborator INDUSTRY

  • Novartis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-04-30
Completion
2020-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Finland
  • Germany
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02565511 on ClinicalTrials.gov