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

Division: Psychiatry

Therapeutic Area: Other

Phase: Phase II/III

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 10/5/2017


Purpose/Abstract:


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.




Eligibility Criteria:


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.

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.


Gender: All

Minimum Age: 60 Years

Maximum Age: 75 Years

Accepts healthy volunteers: Accepts Healthy Volunteers

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Belinda Robertson, Clinical Research Coordinator
(305) 243 2891
b.ryan1@miami.edu

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