TRx0237 for Mild to Moderate Alzheimer's Disease
TRx0237 for Mild to Moderate Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
The purpose of this Phase III study is to determine the safety and efficacy of the experimental drug TRx0237 to treat people with mild to moderate Alzheimer's disease.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
N/A | 89 Years | Both | No |
Inclusion Criteria:
- Diagnosis of dementia and probable Alzheimer's disease
- Clinical Dementia Rating (CDR) total score of 1 to 2; Mini-Mental State Examination (MMSE) score of 14-26 (inclusive); Modified Hachinski ischemic score of 4 or less
- Women of childbearing potential must use adequate contraception or practice abstinence and agree to maintain this throughout the study
- Participant or his/her representative can read and understand the language of the study site
- Caregiver who will provide written informed consent for his/her own participation; can read, understand, and speak the language of the study site; lives with the participant or sees him/her for at least 2 hours per day on 3 or more days per week; agrees to accompany the participant to each study visit; and can verify daily compliance with the study drug
- If taking an Alzheimer's medication (acetylcholinesterase inhibitor and/or memantine), must have taken the medication for at least 3 months and be on stable dose
Exclusion Criteria:
- Significant central nervous system 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, epilepsy, significant head injury, or unexplained or recurrent loss of consciousness lasting 15 minutes or more
- Major depressive disorder, schizophrenia, or other psychotic disorders; bipolar disorder; substance-related disorders
- Metal implants in the head (except dental), pacemaker, cochlear implants, or any other nonremovable items that preclude MRI
- Living in a hospital or moderate- to high-dependency continuous care facility
- History of swallowing difficulties
- Pregnant or breastfeeding
- Glucose-6-phosphate dehydrogenase deficiency
- Current or past significant blood-related abnormality
- Abnormal laboratory test results at screening as deemed by the investigator
- Clinically significant cardiovascular disease or abnormal assessments
- Pre-existing or current signs of respiratory failure
- Concurrent clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease
- Diagnosis of cancer within the past 2 years (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer), unless treatment has resulted in complete freedom from cancer for at least 2 years
- Prior intolerance or hypersensitivity to methylthioninium-containing drug or similar organic dyes
- Prohibited medications: Tacrine; anxiolytics and/or sedatives/hypnotics taken prior to cognitive testing (exceptions: sedation for imaging or occasional short-acting benzodiazepines, chloral hydrate, or zolpidem as needed at bedtime); clozapine, olanzapine, carbamazepine, primidone, or drugs associated with methemoglobinemia
- Current or recent participation in another clinical trial
Detailed Description:
In this study, researchers will test the drug TRx0237 (also called LMTX™) as a treatment for mild to moderate Alzheimer's disease. Results of cognitive testing and brain imaging will be compared between participants receiving one of two doses (125 mg/day or 250 mg/day) and those taking a placebo. The drug acts by reducing levels of aggregated or misfolded tau proteins, which are associated with the progressive neurodegeneration of Alzheimer’s disease.
Central Contact Information:
For more information about this trial or its study sites, please contact Bernard Hall at 1-800-910-5609 or info@alzheimersstudies.net.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 33.599722, -117.699444 | Laguna Hills | California | Recruiting | Name: Phone: | ||
Geolocation is 34.0522342, -118.2436849 | Los Angeles | California | Not yet recruiting | Name: Phone: | ||
Geolocation is 41.308274, -72.9278835 | New Haven | Connecticut | Not yet recruiting | Name: Phone: | ||
Geolocation is 26.4614625, -80.0728201 | Delray Beach | Florida | Recruiting | Name: Phone: | ||
Geolocation is 30.3321838, -81.655651 | Jacksonville | Florida | Recruiting | Name: Phone: | ||
Geolocation is 25.7889689, -80.2264393 | Miami | Florida | Recruiting | Name: Phone: | ||
Geolocation is 33.7748275, -84.2963123 | Decatur | Georgia | Recruiting | Name: Phone: | ||
Geolocation is 42.7762015, -71.0772796 | Haverhill | Massachusetts | Recruiting | Name: Phone: | ||
Geolocation is 40.2962222, -74.0509725 | Eatontown | New Jersey | Recruiting | Name: Phone: | ||
Geolocation is 39.8912248, -74.9218324 | Marlton | New Jersey | Recruiting | Name: Phone: | ||
Geolocation is 40.716111, -74.3625 | Summit | New Jersey | Recruiting | Name: Phone: | ||
Geolocation is 39.9537358, -74.1979458 | Toms River | New Jersey | Recruiting | Name: Phone: | ||
Geolocation is 42.6525793, -73.7562317 | Albany | New York | Recruiting | Name: Phone: | ||
Geolocation is 40.65, -73.95 | Brooklyn | New York | Recruiting | Name: Phone: | ||
Geolocation is 40.0959438, -75.1251743 | Jenkintown | Pennsylvania | Recruiting | Name: Phone: | ||
Geolocation is 30.267153, -97.7430608 | Austin | Texas | Not yet recruiting | Name: Phone: | ||
Geolocation is 49.8879519, -119.4960106 | Kelowna | British Columbia | Not yet recruiting | Name: Phone: | ||
Geolocation is 45.0769115, -64.4944735 | Kentville | Nova Scotia | Not yet recruiting | Name: Phone: | ||
Geolocation is 43.7615377, -79.4110794 | North York | Ontario | Recruiting | Name: Phone: | ||
Geolocation is 45.5086699, -73.5539925 | Montreal | Quebec | Not yet recruiting | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
TauRx Therapeutics Ltd. |
Collaborator Sponsor:
Facility Investigators:
Study Contact:
| Name | Phone | |
|---|---|---|
Bernard Hall | 1-800-910-5609 |
Locations
ClinicalTrials.gov ID
NCT01689246 (follow link to view full record on ct.gov in new window)
Official Title:
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Study Start Date:
December 2012
Study End Date:
March 2015
Disease Stage:
Early
Middle
Enrollment:
833
