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GENERATION study

Clinical Trials Watch

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Study Information

Name of the study

A Study of CAD106 and CNP520 versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

The study (also known as the API APOE4 trial) is conducted as part of the Alzheimer's Prevention Initiative (API) programme.

Study sponsor

Novartis

Disease

People at higher risk of developing Alzheimer’s dementia. 

Information about the drug that will be tested in the study

Name of drug

This study will test two different drugs, namely CAD106 and CNP520

Administration

  • CAD106: is an intramuscular injection.
  • CNP520: is a capsule taken orally.

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the drugs (CAD106 or CNP520) or the corresponding placebo:

CAD106: Participants will be given an injection at weeks 1, 7 and 13. From week 13 onwards, they will receive an injection approximately every 3 months.

Placebo: Participants will be given an injection with placebo (a dummy treatment) at weeks 1, 7, 13. From week 13 onwards, they will receive an injection with placebo approximately every 3 months.

CNP520: capsule taken once a day.

Placebo: (a dummy treatment) capsule taken once a day.

Neither the participant nor his/her 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.generationstudy.com/)

How long will the treatment last?

Approximately 5 years.

What will your involvement entail?

  • During the study, participants will need to attend regular study appointments with the study doctor and research staff and will need to complete different tests that will assess their cognition.
  • Participants will be required to undergo two brain scans (PET) during the course of the study.
  • 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, the person must:

  • Be 60 to 75 years old.
  • Have normal memory and thinking ability.
  • Be at a higher risk of developing the disease based on their genetic background (“Homozygous APOE4 genotype”).
  • Be willing to have a study partner.

If women, be post-menopausal and not of childbearing potential.

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 (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.
  • Drug abuse.
  • 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).

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 country involved in the trial

  • Finland
  • Switzerland

Estimated start date of recruitment

August 2016 for Europe

Information for your doctor

EudraCT Number:

2015–002715-15

Clinicaltrials.gov identifier

NCT02565511

Study contact information

Clinicaltrial.enquiries@novartis.com

Novartis pharmaceuticals: 1-888-669-6682 / +41-61-324-11-11

Study website

http://www.generationstudy.com/

Link to full text

https://clinicaltrials.gov/ct2/results?term=NCT02565511&Search=Search&view=record

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-002715-15

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on May2017.

This document has not 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.

 

 

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Last Updated: Monday 29 May 2017

 

 
 

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