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GENERATION S2 study

Clinical Trials Watch

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Study Information

Scientific title

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

Study sponsor

Novartis

Disease

People at higher risk of developing Alzheimer’s disease

Phase

Phase 2/3

Information about the drug that will be tested in the study

Name of the drug

CNP520

Administration

A capsule taken orally once a day

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

  • A capsule of 15 mg of CNP520
  • A capsule of 50 mg of CNP520
  • A capsule of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested).

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The investigational drugs used in the trial are being studied because they may help prevent a substance called amyloid beta from building up in the brain, which has been shown to be associated with the development of Alzheimer's disease. The goal of this study is to test the effectiveness of these medications as compared to placebo for preventing or delaying the onset of Alzheimer's disease symptoms (information taken from http://www.generationprogram.com/).

How long will the treatment last?

  • Approximately 5 years
  • Up to an expected maximum of 7 years

What your involvement will entail?

  • Participants will receive disclosure of their individual test results for APOE genotyping and brain amyloid status
  • During the study, participants will need to attend regular study appointments with the study doctor and research staff
    • to complete different tests that will assess their cognition
    • for drug dispensing, safety and efficacy assessments
  • Participants will be required to undergo brain scans (MRI) during the course of the study (Month 6, Month 12 and on a yearly basis thereafter)
  • Additional brain scans (PET), blood collection and lumbar puncture (CSF) will be voluntary

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be 60 to 75 years old
  • Have normal memory and thinking ability
  • Be willing to have a study partner
  • If women, be post-menopausal and not of childbearing potential
  • Be at a higher risk of developing the disease based on their genetic background (individuals who have at least one APOE4 allele, plus a positive amyloid test if they have only one APOE4 allele).

Who cannot participate in the study?

Exclusion criteria include:

  • A disability that may prevent the participant from completing the study
  • A medical or neurological condition that could impact on the cognition or on the performance of the participant on cognitive assessments (e.g. dementia, Huntington’s disease, Parkinson’s disease, Lyme disease, schizophrenia, bipolar disorder, major depression, active seizure disorder, history of multiple traumatic brain injuries, alcohol/drug abuse or dependence currently, or dependence within the last two years)
  • A disease that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk (e.g. active hepatitis, HIV infection, severe renal impairment, severe hepatic impairment, uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure)
  • History of malignancy of any organ within the past 5 years
  • Treatment with any of the approved anti-dementia drugs (e.g. donepezil, rivastigmine, galantamine, memantine)
  • Contraindication or intolerance to brain scans (MRI or PET)
  • Brain scan (MRI) results showing findings that are not related to Alzheimer’s disease and that, in the opinion of the investigator might be a leading cause to cognitive decline or might pose a risk to the participant
  • Suicidal thoughts in the past six months, or suicidal behaviour in the past two years
  • Significantly abnormal laboratory results at screening, not as a result of a temporary condition
  • Current clinically significant findings in the electrocardiogram (ECG, a test that records the electrical activity of the heart)
  • Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active/history of chronic urticarial (hives) in the past year

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Where and when will the study be conducted?

European countries involved in the trial

  • Belgium
  • Finland
  • France
  • Iceland
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • Switzerland
  • UK

Estimated start date of recruitment

August 2017

Information for your doctor

EudraCT Number:

2016-002976-28

Clinicaltrials.gov identifier

NCT03131453

Study contact information

Novartis Pharmaceuticals

trialandresults.registries@novartis.com

info@generationprogram.com

Link to full text

https://www.clinicaltrials.gov/ct2/show/study/NCT03131453?term=cnp520&recrs=ab&rank=1&show_locs=Y#locn

Study website

http://www.generationprogram.com/

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on July 2018.

This document has been reviewed by the pharmaceutical company running this trial.

This document has been reviewed by a member of the European Working Group of People with Dementia.

 

 
 

Last Updated: Monday 09 July 2018

 

 
 

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