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TRx0237 for Mild Alzheimer's

Start: January 10, 2018
End: March 2023
Enrollment: 375

What Is This Study About?

TRx0237 (also known as LMTX) is a small molecule drug being tested for its ability to inhibit aggregation of tau, a protein that forms neurofibrillary tangles in the brains of people with Alzheimer's and other neurodegenerative diseases. This Phase 2/3 study will test the safety and efficacy of the experimental drug TRx0237 in older adults with mild Alzheimer's disease. Participants in this study will be randomized to take either 8 mg or 16 mg of the study drug daily or placebo for 39 weeks. Researchers will measure changes in tau levels as seen on PET scans, as well as changes in brain atrophy (measured by MRI), cognitive function, and activities of daily living.

Do I Qualify To Participate in This Study?

Minimum Age: N/A

Maximum Age: 90 Years

Must have:

  • Diagnosis of early Alzheimer's Disease, including probable AS and MCI due to AD
  • Documented PET scan that is positive for amyloid
  • Mini-Mental State Examination score of 20 to 25 and Clinical Dementia Rating of 0.5
  • Global Clinical Dementia Rating (CDR) of 0.5
  • Females must be post-menopausal, be surgically sterile, have undergone bilateral tubal occlusion/ligation, or use adequate contraception
  • Able to read and understand in the language of the study site
  • Study partner who either lives with the participant or sufficient contact to provide assessment of changes over time, is fluent in the study site language, can attend study visits, and can verify the participant takes the study drug daily

Must NOT have:

  • Significant central nervous system disorder other than probable AD or MCI-AD
  • Significant intracranial focal or vascular pathology seen on magnetic resonance imaging (MRI) scan
  • Clinical evidence or history of cerebrovascular accident, transient ischemic attack (mini-stroke), significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment, or other unexplained or recurrent loss of consciousness for 15 minutes or more
  • Epilepsy
  • Major depressive disorder, schizophrenia and other psychotic disorders, bipolar disorder, and substance-related disorders, including alcohol
  • Non-removable items that could interfere with ability to undergo MRI, including metal implants in the head, pacemaker, and cochlear implants
  • Reside in hospital or moderate- to high-dependency continuous care facility
  • Any physical disability that would prevent completion of study procedures or assessments
  • History of swallowing difficulties
  • Pregnant or breastfeeding
  • Glucose-6-phosphate dehydrogenase deficiency
  • History of or current significant blood abnormality
  • Abnormal serum chemistry laboratory value at screening
  • Clinically significant heart disease or abnormal assessments
  • Pre-existing or current signs of respiratory failure 
  • Significant immunologic, hepatobiliary, or endocrine disease and/or other unstable or major disease other than probable AD or MCI-AD
  • Diagnosis of cancer in past 2 years
  • Intolerance or hypersensitivity to methylthioninium-containing drugs or methemoglobinemia induced by such drugs, similar organic dyes, or any related components
  • Prohibited medications (within past 90 days): Souvenaid, clozapine, carbamazepine, primidone, valproate, or drugs for which there is a warning or precaution in the labeling about methemoglobinemia
  • Current or previous participation in another TRx0237 trial
  • Participation in a trial testing a drug, biologic, device, or medical food within 28 days prior to baseline or of a cognition-related product within 90 days prior to baseline unless part of the control group

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.


Who Is the General Study Contact?

For more information about this study or study sites, contact Marcus Wischik at

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: TauRx Therapeutics Ltd

Source: ID: NCT03446001