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LUCIDITY study

Clinical Trials Watch

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Study Information

Scientific title

Brain Imaging and Safety Study Evaluating TRx0237 in Subjects With Mild Alzheimer's Disease

Study sponsor

TauRx Therapeutics Ltd

Disease

People with mild Alzheimer's disease 

Phase

Phase 3

Information about the drug that will be tested in the study

Name of drug

TRx0237

Administration

A tablet taken orally twice a day

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:

  • A tablet of 4 mg of TRx0237 administered twice daily (8 mg/day)
  • One placebo tablet administered twice daily (also called a dummy treatment which is 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 this study is to determine the safety and efficacy of TRx0237 to delay the progression of the pathology in people with mild Alzheimer's Disease

How long will the treatment last?

6 months

What will your involvement entail?

  • During the study participants will be asked to undertake two brain scans (i.e. MRI, PET scans)
  • Participants will be requested to complete oral and written tests evaluating cognitive assessments. They should be accompanied by their study partner
  • Participants will be also requested to complete some laboratory tests to evaluate the side effects (it refers to unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
  • Further information on the procedures, tests and 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:

  • Up to 90 years of age
  • Have a diagnosis of probable Alzheimer’s disease
  • Have a score between 20-25 points in the MMSE test (a test about your memory) and 0.5 in the Clinical Dementia Rating-Global Score (CDR-GS). This would suggest that the person has an impairment in their memory that is still at a mild stage
  • Be fluent in the language used at the study site
  • Be willing to have at least a study partner who has a sufficient contact with the participant, is willing to accompany the participant to all study visits, provides the necessary information about the participant’s memory, behaviour and functioning
  • Must not be taking an anti-dementia drug (e.g. acetylcholinesterase inhibitor, memantine) for at least 3 month prior to the screening visit
  • Females must be surgically sterile (e.g. have undergone surgical operation, be post-menopausal, or use adequate contraception).

Who cannot participate in the study?

Exclusion criteria include:

  • Brain scan results showing findings that are not related to probable Alzheimer’s disease
  • Any other type of neurological disease that is not Alzheimer’s disease (e.g. epilepsy)
  • History of schizophrenia (mental disorder which affects how a person thinks, feels and acts) or other depressive disorder
  • Alcohol or drug abuse or dependence
  • Treatment with other medications known to potentiate experimental drug’s effects (e.g. antipsychotics)
  • Diagnosis of cancer within the past 2 years except if considered to not being linked  with the disease  for at least 2 years
  • Have any contraindication to brain MRI scans (due to having prostheses, implants, a pacemaker or claustrophobia)
  • Clinically significant cardiovascular or symptoms of respiratory failure
  • A pregnancy or breast-feeding for female participants
  • Resides in dependency facilities (i.e. hospital, care facility)

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

  • UK

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

  • Belgium
  • Italy
  • Poland
  • Spain

Estimated start date of recruitment

January 2018

Information for your doctor

Clinicaltrials.gov identifier

NCT03446001

Study contact information

Marcus Wischik

+44 (0)1224 440935

info@taurx.com

Link to full text

https://clinicaltrials.gov/ct2/show/NCT03446001?term=TRx0237&rank=3

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on November 2018.

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.

 

 
 

Last Updated: Thursday 15 November 2018

 

 
 

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