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VIVIAD

Phase II trials

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Study Information

Name of the study

A Study to Evaluate Safety and Tolerability of Different Doses and Efficacy of PQ912 in Subjects With MCI and Mild AD

Study sponsor

Vivoryon Therapeutics AG

Disease

Mild cognitive impairment and mild Alzheimer’s disease

Phase

Phase II

Information about the drug that will be tested in the studies

Name of the drug

PQ912

Administration

Tablet

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 oral tablet of PQ-912 once daily (evening)
  • Anoral tablet of placebo (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 purpose of the study is to evaluate the safety, tolerability and efficacy of PQ912 in people with mild cognitive impairment and mild dementia due to Alzheimer's disease.

How long will the treatment last? 

The duration of participation in the study is either 48, 60, 72, 84 or 96 weeks of treatment.

What will your involvement entail?

  • During the study, participants will have to undergo brain scan (MRI) to see if they have amyloid pathology in their brain
  • Complete some laboratory tests and neurological examinations to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
  • During the study, participants will be asked to complete other tests that will assess their memory, functioning, attention and psychomotor function (i.e. tests or scales like CBB-Z, NTB)
  • Do physical examination and an electroencephalography (a test that records the electrical activity of the brain).

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 80 years old
  • Have a diagnosis of mild cognitive impairment or mild Alzheimer’s disease according to the National Institute on Aging/Alzheimer's Association core clinical criteria
  • Have adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the investigator
  • Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration.

Who cannot participate in the study?

Exclusion criteria include:

  • Any other type of neurological or psychiatric disease that is not Alzheimer’s disease (e.g. epilepsy) that may affect cognition
  • History of schizophrenia (mental disorder which affects how a person thinks, feels and acts) or other depressive disorder
  • History of a stroke, transient ischemic attack or seizures within the past two years
  • Contraindication to 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 countries involved in the trial

  • Denmark
  • Germany 
  • Netherlands

Estimated start date of recruitment

July 2020

Information for your doctor

EudraCT Number

2019-003532-23

Clinicaltrials.gov identifier

 NCT04498650 

Study contact information

Katharina Fuchs  +49 5559900

Kerstin Kuehn-Wache  +49 5559900

 clinics@vivoryon.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT04498650

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

The pharmaceutical company running this trial has not reviewed this document.

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

 

 
 

Last Updated: Monday 18 January 2021

 

 
 

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