Clinical Trial Details

NCT ID: NCT02565511
Date Last Changed: September 27, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using CAD106 Immunotherapy, Placebo to CAD106, CNP520 and Placebo to CNP520 for patients with Alzheimer's Disease

Research Study Title

A Randomized, Double-blind, Placebo-controlled, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease.

Purpose

The purpose of this study is to test whether two investigational drugs called CAD106 and CNP520, administered separately, can 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.

To Learn more

Recruitment Details

Phase
2/3
Gender
All
Age
60 to 75 Years
Overall Status
Recruiting
Lead Sponsor
Novartis Pharmaceuticals
Duration
102 Months
Facility Type
N/A
Compensation

Eligibility

All ages 60 Years to 75 Years

Inclusion Criteria:

  • Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential.

  • Mini-Mental State Examination (MMSE) total score ≥ 24 and cognitively unimpaired as evaluated by memory tests performed at screening.

  • Homozygous APOE4 genotype.

  • Participant's willingness to have a study partner.

Exclusion Criteria:

  • Any disability that may prevent the participants from completing all study requirements.

  • Current medical or neurological condition that might impact cognition or performance on cognitive assessments.

  • Advanced, severe progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the participant at special risk.

  • History of malignancy of any organ system, treated or untreated, within the past 60 months.

  • History of hypersensitivity to any of the investigational drugs or their excipients / adjuvant or to drugs of similar chemical classes.

  • Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine).

  • Contraindication or intolerance to MRI or PET investigations (with fluorinated radio ligands).

  • Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to cognitive decline, might pose a risk to the participant, or might prevent a satisfactory MRI assessment for safety monitoring.

  • Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years.

  • A positive drug screen at Screening, if, in the Investigator's opinion, this is due to drug abuse.

  • Significantly abnormal laboratory results at Screening, not as a result of a temporary condition.

  • Current clinically significant ECG findings.

For Cohort - II only:

• Participants with depigmenting or hypopigmenting conditions (e.g. albinism vitiligo) or active / history of chronic urticarial in the past year.

Site Locations (34)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85006 Banner Alzheimer's Institute
602-839-6500
roma.patel@bannerhealth.com
United States Arizona Scottsdale 85259 Mayo Clinic Arizona
480-301-6726
Thomas.martha1@mayo.edu
United States Arizona Sun City 85351 Banner Sun City Research Institute
623-832-6500
bannerresearch@bannerhealth.com
United States California Costa Mesa 92626 ATP Clinical Research, Inc.
714-277-4472
info@atpcr.com
United States Connecticut New Haven 06510 Yale University Alzheimer's Disease Research Unit
203-764-8100
Emily.kemp@yale.edu
United States District of Columbia Washington, D.C. 20057 Georgetown University
202-687-8800
mj582@georgetown.edu
United States Florida Jacksonville 32224 Mayo Clinic Jacksonville
904-953-8014
Walkermoore.kimpoki@mayo.edu
United States Florida The Villages 32162 Compass Research
352-261-0901
kyle.moeder@compass.bioclinica.com
United States Georgia Columbus 31909 Medical Research & Health Education Foundation, Inc.
706-653-8455
Research4@stork.md
United States Illinois Chicago 60612 Rush University Medical Center
312-942-0050
United States Illinois Chicago 60640 Great Lakes Clinical Trials
773-275-3500
info@greatlakesclinicaltrials.com
United States Indiana Indianapolis 46202 Indiana University
317-963-7440
aklaehn@iupui.edu
United States Kansas Fairway 66205 University of Kansas Alzheimer's Disease Center
913-588-0555
kuamp@kumc.edu
United States Nebraska Omaha 68198-7680 Memory Disorders Program, Department of Neurological Sciences, University of Nebraska Medical Center
402-552-6233
rhogue@unmc.edu
United States Nevada Las Vegas 89106 Cleveland Clinic Lou Ruvo Center for Brain Health
702-483-6026
brainhealth@ccf.org
United States New York New York 10016 NYU Langone Medical Center
212-263-5845
Mrunalini.gaikwad@nyumc.org
United States New York Orangeburg 10962 The Nathan S. Kline Institute
845-398-5582
Sameh.Nosir@nki.rfmh.org
United States New York Rochester 14620 University of Rochester Medical Center
585-760-6562
Susan_salem-spencer@urmc.rochester.edu
United States North Carolina Charlotte 28270 Alzheimer's Memory Center
704-364-4000 ext. 235
hswierc@amcneurology.com
United States North Carolina Durham 27705 Duke University Medical center
919-668-2841
Jessica.carlson@duke.edu
United States Ohio Beachwood 44122 University Hospitals Cleveland Medical Center / Case Western Reserve University
216-464-6474
parrianne.fatica@uhhospitals.org
United States Pennsylvania Willow Grove 19090 Abington Neurological Associates
215-957-9250
denisegallagher.ana@gmail.com
United States Rhode Island Providence 02906 Butler Hospital Memory and Aging Program
401-455-6402
memory@butler.org
United States South Carolina Charleston 29401 Roper St. Francis - CBRI
843-724-2302
Allison.lapp@rsfh.com
United States Texas Austin 78757 Senior Adults Specialty Research
512-407-8628
mdraper@senioradults.net
United States Texas Houston 77074 Clinical Trial Network
713-484-6947
mespiritu@ctntexas.com
United States Vermont Bennington 05201 The Memory Clinic
802-447-1409
megan@memorydoc.org
United States Wisconsin Milwaukee 53226 The Medical College of WI
414-805-8328
bblaney@mcw.edu
Belgium Leuven 3000 Novartis Investigative Site
Canada Ontario Toronto M3B 2S7 Toronto Memory Program
416-386-9606
research@memorydisorders.ca
Finland Turku 20520 Novartis Investigative Site
Netherlands Amsterdam 1081 GN Novartis Investigative Site
Spain Barcelona 08005 Novartis Investigative Site
Switzerland Lausanne CH-1011 Novartis Investigative Site

Contact

Novartis Pharmaceuticals
1-888-669-6682
E-mail:

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