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



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:60 - 75
Updated:3/30/2019
Start Date:February 5, 2016
End Date:January 31, 2025
Contact:Novartis Pharmaceuticals
Email:trialandresults.registries@novartis.com
Phone:1-888-669-6682

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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.

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.

This study will assess the effects of each of the two therapies given separately, both
targeting amyloid, on cognition, global clinical status, and underlying pathology in
participants at risk for the onset of clinical symptoms of Alzheimer's disease (AD).
Cognitively unimpaired individuals with two APOE4 genes and age 60 to 75 years, inclusive,
are selected as they represent a population at particularly high risk of progression to Mild
Cognitive Impairment and/or dementia due to Alzheimer's disease.

The study follows a randomized, double-blind, placebo-controlled, two-cohort, parallel group
design in which participants receive one of the investigational treatments or their matching
placebo for at least 60 months up to a maximum of 96 months and no longer than when the
target number of events for the TTE endpoint has been observed and confirmed in either
cohort.

An unbalanced randomization (active: placebo) of 5:3 ratio in Cohort I (430 CAD106 :260
Placebo) and 3:2 ratio in Cohort II (390 CNP520 : 260 Placebo) will be applied. Randomization
will be stratified by age group (60-64 years, 65-75 years) and region (North America/Other ,
Europe).

Participants who meet study entry requirements will be required to undergo at least one PET
scan during the course of the study. Additional PET scans, blood and CSF collection will be
voluntary. The study (also known as the Generation Study 1) is conducted as part of the
Alzheimer's Prevention Initiative (API) program.

Key Inclusion Criteria:

- Consent to receive disclosure of their risk estimates to develop clinical symptoms of
AD based on their APOE genotype.

- 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 (at screening or in previous 3
months) and cognitively unimpaired as evaluated by memory tests performed at
screening.

- Homozygous APOE4 genotype.

- Participant's willingness to have a study partner.

Key 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 future 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, or infection not as a result
of a temporary condition.

- Current clinically significant ECG findings. For Cohort - I only: Participants with
previous organ transplantation or stem cell transplantation, or indication for
treatment with anti-coagulants.

For Cohort - II only: Participants with depigmenting or hypopigmenting conditions (e.g.
albinism vitiligo) or active / history of chronic urticarial in the past year.
We found this trial at
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-760-6562
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 713-486-0500
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 317-963-7440
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Miami, Florida 33124
(305) 284-2211
Phone: 305-355-9120
University of Miami A private research university with more than 15,000 students from around the...
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Phone: 407-210-1337
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
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Atlanta, Georgia 30322
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Atlantis, Florida 33462
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Austin, Texas 78757
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Basalt, Colorado 81621
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Basalt, Maine
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11100 Euclid Avenue
Beachwood, Ohio 44122
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Bennington, Vermont 05201
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Boca Raton, Florida 33431
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Boston, Massachusetts 01801
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Boston, Massachusetts 02118
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Centerville, Ohio 45459
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Charleston, South Carolina 29401
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Charlotte, North Carolina 28211
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-0050
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, Illinois 60640
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Columbus, Georgia 31909
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Darlinghurst, New South Wales 2010
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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6550 Fannin St
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Phone: 202-687-8800
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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