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Phase II trials

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Study Information

Name of the study

A multiple ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7126209 following intravenous infusion in participants with prodromal or mild to moderate Alzheimer's disease

Study sponsor

Hoffmann-La Roche

Disease

Prodromal or mild to moderate Alzheimer's disease

Phase

Phase I/II

Information about the drug that will be tested in the studies

Name of the drug

RO7126209

Administration

The drug will be administered via an intravenous infusion (an injection into the vein) once every 4 weeks.

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 intravenous infusion of RO7126209 (one of the four doses)
  • An intravenous infusion of placebo (a substance which looks like the trial drug but has no study drug in it).

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 this study is to evaluate the safety and tolerability of multiple-ascending intravenous doses of RO7126209 in people with prodromal or mild to moderate Alzheimer's disease, who are amyloid positive based on amyloid positron emission tomography (PET) scan.

How long will the treatment last? 

28 weeks of treatment followed by a 28-week safety follow-up period.

What will your involvement entail?

  • During the study, participants will have to complete a PET brain scan or CSF examination (lumbar puncture) to see if they have amyloid pathology in their brain
  • Complete some laboratory tests (i.e. blood pressure, heart rate) to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
  • Complete a test that will assess memory, orientation, judgment and problem solving, personal care and community affairs which is a test called Clinical Dementia Rating (CDR).

Further information on the procedures 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 50 to 85 years old
  • Have a diagnosis of probable mild to moderate Alzheimer’s disease according to the National Institute on Aging/Alzheimer's Association core clinical criteria
  • Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration
  • Have a score of 0.5 to 2 in the Clinical Dementia Rating-Global Score (CDR) and a score of 18 to 28 in the MMSE test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
  • Have evidence of abnormal accumulation of amyloid in their brain (PET scan)
  • If the person is taking approved symptomatic medication for dementia (i.e. donepezil, rivastigmine or galantamine) the dosing regimen must have been stable
  • Agree to not participate in other clinical studies for the duration of this study.

Who cannot participate in the study?

Exclusion criteria include:

  • Ongoing neurological disorders, major psychiatric disorder, systematic vascular disease, intracranial mass or medical condition that may interfere with the safety or study assessments or could be the cause of the cognitive impairment
  • Any other type of disease that may interfere with the study (i.e. hematological, ophthalmologic, cardiovascular diseases)
  • Brain scans showing significant abnormality
  • Contraindication to PET imaging, MRI procedures and lumbar puncture.

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 (active)

  • Spain

European country that will be involved in the trial (planned)

  • Poland

Estimated start date of recruitment

March 2021

Information for your doctor

EudraCT Number

2020-002477-98

Clinicaltrials.gov identifier

NCT04639050

Study contact information

global-roche-genentech-trials@gene.com

Link to full text

https://www.clinicaltrials.gov/ct2/show/NCT04639050

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on February 2021.

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.

 

 
 

Last Updated: Monday 15 March 2021

 

 
 

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