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Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

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Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease

NCT01689246•TauRx Therapeutics Ltd

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild to moderate Alzheimer's Disease.

Eligibility

Age

0 - 89 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of all cause dementia and probable Alzheimer's disease
•Clinical Dementia Rating (CDR) total score of 1 (mild) to 2 (moderate) and MMSE score of 14-26 (inclusive)
•Age \< 90 years
•Modified Hachinski ischemic score of ≤ 4
•Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study
•Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent
•Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug
•If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of Screening, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study.
•Able to comply with the study procedures

Exclusion Criteria

•Significant central nervous system (CNS) disorder other than Alzheimer's disease
•Significant focal or vascular intracranial pathology seen on brain MRI scan
•Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes
•Epilepsy
•Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders
•Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI
•Resides in hospital or moderate to high dependency continuous care facility
•History of swallowing difficulties
•Pregnant or breastfeeding
•Glucose-6-phosphate dehydrogenase deficiency
+15 more criteria

Locations (121)

Xenoscience, Inc/ 21st Century Neurology

Phoenix, Arizona, United States

Feldman, Robert MD

Laguna Hills, California, United States

University of Southern California

Los Angeles, California, United States

Shankle Clinic and Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Pacific Research Network

San Diego, California, United States

San Francisco Clinical Research Center

San Francisco, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

JEM Research

Atlantis, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

CNS Healthcare, Inc

Jacksonville, Florida, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

November 1, 2015

Completion Date

November 1, 2015

Last Updated

March 14, 2018

Enrollment

891

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

TRx0237 150 mg/day

DRUG

TRx0237 250 mg/day

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

View study

RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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