Safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS-MAPTRx in patients with mild Alzheimer's disease
Information about the drug that will be tested in the study
Administration
The drug was 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 at random to either receive one of the following options:
- An intrathecal injection of IONIS-MAPTRx, 4 different dose levels were 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 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 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 were planned for dosing and 5 visits in between doses and as follow-up (post-treatment).
What your involvement will entail?
During the study, participants were 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.
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?
People cannot take part in the study if they have or have experienced:
- 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.
Information for your doctor
EudraCT Number
2016-002713-22
Clinicaltrials.gov identifier
NCT03186989
Study contact information
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 February 2020.
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.
