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MAPT-CS1

Phase II trials

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Study Information

Scientific title

Safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS-MAPTRx in patients with mild Alzheimer's disease

Study sponsor

Ionis Pharmaceuticals

Disease

Mild Alzheimer's disease

Phase

Phase I/II

Information about the drug that will be tested in the study

Name of drug

IONIS MAPTRx

Administration

The drug will be administered via an intrathecal injection (an injection into the spinal canal) every month during 3 months.

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:

  • An intrathecal injection of IONIS-MAPTRx, 4 different dose levels will be tested
  • An intrathecal injection of placebo (a substance identical in appearance to the drug being tested with no active therapeutic effect).

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 purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS-MAPTRx in people with mild Alzheimer's disease.

How long will the treatment last? 

  • Around 10 months
  • 4 visits are planned for dosing and 5 visits in between doses and as follow-up (post-treatment).

What will your involvement entail?

During the study, participants will be asked to:

  • Do laboratory tests to evaluate the emergent adverse events (unfavourable signs, symptoms, diseases temporally associated with the use of the drug tested in the study)
  • Do some blood tests
  • Undergo regular brain scans (MRI) and CSF examination (spinal tap) during the course of the study.

Further information on the 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 between 50 and 74 years old, inclusive
  • Have a diagnosis of mild Alzheimer’s disease including evidence of abnormal accumulation of amyloid or Tau protein in their brain (CSF examination)
  • Have a body mass index between 18 and 35 kg/m2 and total body weight > 50 kg
  • Have a study partner who has a sufficient contact with the participant, is willing to accompany the participant to all study visits and to be available by phone if needed.

Who cannot participate in the study?

Exclusion criteria include:

  • A medical condition that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk
  • Utilisation of certain brain or antipsychotic drugs within the past month.

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

  • Finland
  • Germany
  • Netherlands
  • Sweden
  • UK

Estimated start date of recruitment

June 2017

Information for your doctor

EudraCT Number

2016-002713-22

Clinicaltrials.gov identifier

NCT03186989

Study contact information

patients@ionisph.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT03186989

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on January 2019.

The pharmaceutical company running this trial has reviewed this document.

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

 

 

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Last Updated: Friday 08 March 2019

 

 
  • Acknowledgements

    Alzheimer Europe's Clinical Trial Watch received funding under an operating grant from the European Union’s Health Programme (2014–2020).
  • European Union
 
 

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