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T-817MA

Phase II trials

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Study Information

Name of the study

Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD

Study sponsor

FUJIFILM Toyama Chemical Co., Ltd.

Disease

Alzheimer's disease

Phase

Phase II

Information about the drug that will be tested in the study

Name of drug

T-817MA (also named Edonerpic)

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 T-817MA (224mg) once daily for first 4 weeks and then two oral tablets of T-817MA (448mg) for the following weeks
  • An oral 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 efficacy and safety of T-817MA in people with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer's disease.

How long will the treatment last? 

Around 1.5 year (5 visits)

What will your involvement entail?

  • During the study, participants will have to undergo brain scan (MRI) and CSF examination (spinal tap) to see if they have amyloid pathology in their brain
  • Complete a memory test (MMSE) to assess cognitive function
  • Complete a test that will assess memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR)
  • Perform an electroencephalogram (this is a test or record of brain electrical activity using electrodes placed along the scalp)
  • Complete some laboratory tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).

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 due to Alzheimer’s disease or mild Alzheimer’s disease according to the National Institute on Aging/Alzheimer's Association core clinical criteria
  • Have evidence of abnormal accumulation of amyloid and p-tau181 in their brain (as per results of CSF examination (spinal tap)
  • Have a score between 24 and 30 points 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 very mild stage
  • Be post-menopausal or permanently sterilized for female participants
  • Be required to use highly effective methods of contraception during the study and until 104 days after the last dose for male participants
  • If the person is taking acetylcholinesterase inhibitors as an approved anti-dementia medication (i.e. donepezil, rivastigmine, galantamine) the dosing regimen must have been stable for at least 3 months prior to the screening visit
  • 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:

  • Contraindication to PET imaging, MRI procedures and lumbar puncture
  • Any results within the previous two years that showed a pathology inconsistent with a diagnosis of Alzheimer’s disease
  • A current treatment of memantine.

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

  • Czech Republic
  • Germany 
  • Hungary
  • Netherlands
  • Spain
  • UK

Estimated start date of recruitment

December 2019

Information for your doctor

EudraCT Number

2018-003567-66

Clinicaltrials.gov identifier

NCT04191486  

Study contact information

Larah de Groot

+31 30 656 9186

larah.degroot@juliusclinical.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT04191486

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on May 2020.

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: Monday 18 May 2020

 

 
 

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