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Novartis - BANNER Study for Alzheimer's Disease Risk - Clinical Trial

What is the Purpose of this Study?

We are doing this study to understand how you might feel about learning your genetic risk for AD and learn how well a new drug and a new vaccine work to help prevent AD in people with the APOE4 genetic mutation.

What is the Condition Being Studied?

Alzheimer's disease

Who Can Participate in the Study?

Healthy volunteers ages 60 to 75.

Age Group
Adults

What is Involved?

This study is being done in two parts.

If you choose to join this study, you will start in Part 1 you will:
- Be screened for the APOE4 gene
- Complete questionnaires about your mood and behavior and knowledge of Alzheimer's disease (AD)
- Complete memory and thinking tests
- Be asked whether you want to know if you have the APOE4 gene and what that means for your risk of AD
- Have follow-up phone calls for about a year

If you are able and choose to continue in Part Two of the study, you will:
- Be placed into one of two groups (called cohorts):
-- Cohort 1 patients will be randomized (like flipping a coin) to get:
--- An intramuscular injection of an investigational vaccine called CAD106 or
--- A placebo ('sugar' water) injection

-- Cohort 2 patients will be randomized to get:
--- An investigational oral drug called CNP520 or
--- A placebo

Everyone will have physical exams, lab work, and questionnaires at various study visits

Study Details

Full 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
Principal Investigator
Protocol Number
IRB:PRO00070513
NCT:NCT02565511
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698