CAPI015A2201J: 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
Investigator: Elizabeth Crocco
Institutional Protocol #: 20150891
National Clinical Trials Identifier: NCT02565511
Funding Agency/Sponsor: Novartis
Therapeutic Area: Other
Phase: Phase II/III
Enrolling Sites: University of Miami Medical Group
Enrolling Since: 10/5/2017
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.
- 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
- Homozygous APOE4 genotype.
- Participant's willingness to have a study partner.
- Any disability that may prevent the participants from completing all study
- 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
- 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.
- Contraindication or intolerance to MRI or PET investigations (with fluorinated radio
- 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
- 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
- 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.
Minimum Age: 60 Years
Maximum Age: 75 Years
Accepts healthy volunteers: Accepts Healthy Volunteers
Belinda Robertson, Clinical Research Coordinator
(305) 243 2891