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Novartis - Gen II Study for Patients at Risk for Developing Alzheimer's Disease - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn whether a study drug called CNP520 is safe and has good effects in people who may be at a higher risk for symptoms of Alzheimer's disease due to their age, genetics, and the presence of higher levels of a protein called B-amyloid in their brain.

What is the Condition Being Studied?

People at risk for developing Alzheimer's disease (people with the APOE4 gene)

Who Can Participate in the Study?

Adults age 60-75 years who:
- Are cognitively normal and
- Have a study partner who is in regular contact with them and can come to the study visits and complete interviews with the study doctors.

To continue beyond the screening period, study participants must be APOE genotype carriers.

Age Group
Adults

What is Involved?

The study is divided into two periods, a Screening Period and a Study Dosing Period.

If you choose to join the study, you will
- Go through a Screening Period which lasts about 12 weeks and includes 5-7 visits for
-- Genetic testing for the APOE genotype
-- Interviews with a study doctor for memory testing
-- A brain MRI and PET scan,
-- A lumbar puncture (spinal tap)
-- Blood and urine tests, EKG, neurological and physical exams, and skin exams.

Study Dosing Period: During this period of the study, you will:
- Be randomized (like flipping a coin) to get:
-- A study drug (CNP520) by mouth once a day for 5-8 years
-- A placebo (sugar pill) by mouth once a day for 5-8 years.
- Have visits every 3 months for the first year, then every 6 months until the end of the study.
-- At various visits you will complete questionnaires, have skin checks, EKGs, physical exams, an MRI and/or a PET scan, and lab

Study Details

Full Title
A Randomized, Double-Blind. Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's disease
Principal Investigator
Protocol Number
IRB:PRO00085463
NCT:NCT03131453
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698