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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01689246




Registration number
NCT01689246
Ethics application status
Date submitted
14/09/2012
Date registered
21/09/2012
Date last updated
14/03/2018

Titles & IDs
Public title
Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Scientific title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease
Secondary ID [1] 0 0
TRx-237-015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TRx0237 150 mg/day
Treatment: Drugs - TRx0237 250 mg/day
Treatment: Drugs - Placebo

Experimental: TRx0237 250 mg/day -

Placebo comparator: Placebo -

Experimental: TRx0237 150 mg/day -


Treatment: Drugs: TRx0237 150 mg/day
TRx0237 75 mg tablets will be administered twice daily.

Treatment: Drugs: TRx0237 250 mg/day
TRx0237 125 mg tablets will be administered twice daily.

Treatment: Drugs: Placebo
Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)
Timepoint [1] 0 0
65 weeks
Primary outcome [2] 0 0
Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
Timepoint [2] 0 0
65 weeks
Primary outcome [3] 0 0
Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes
Timepoint [3] 0 0
65 weeks
Secondary outcome [1] 0 0
Change from Baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Timepoint [1] 0 0
65 weeks
Secondary outcome [2] 0 0
Change from Baseline on Mini-Mental Status Examination (MMSE)
Timepoint [2] 0 0
65 weeks
Secondary outcome [3] 0 0
Change in expected decline of whole brain volume as measured by brain MRI
Timepoint [3] 0 0
39 weeks and 65 weeks

Eligibility
Key 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
Minimum age
No limit
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
* History of significant hematological abnormality or current acute or chronic clinically significant abnormality
* Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator
* Clinically significant cardiovascular disease or abnormal assessments
* Preexisting or current signs or symptoms of respiratory failure
* Concurrent acute or chronic 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 prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years
* Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients
* Treatment currently or within 3 months before Baseline with any of the following medications:

* Tacrine
* Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study)
* Carbamazepine, primidone
* Drugs with a warning or precaution in the labeling about methemoglobinemia at approved doses
* Current or prior participation in a clinical trial as follows:

* Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo)
* A clinical trial of a drug, biologic, therapeutic device, or medical food in which the last dose/administration was received within 28 days prior to Baseline

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
891
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Division of Rehabilitation and Aged Care - Hornsby
Recruitment hospital [2] 0 0
Southern Neurology Pty Limited - Kogarah
Recruitment hospital [3] 0 0
Academic Department for Old Age Psychiatry, Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Discipline of Psychiatry, University of Qld - Herston
Recruitment hospital [5] 0 0
Royal Adelaide Hospital Memory Trials Centre - Adelaide
Recruitment hospital [6] 0 0
Memory Unit, Neurology, The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [7] 0 0
Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [8] 0 0
McCusker Alzheimer's Research Foundation Inc - Nedlands
Recruitment hospital [9] 0 0
Neurodegenerative Disorders Research Pty Ltd - Perth
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4006 - Herston
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
6005 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Illinois
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United States of America
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Massachusetts
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United States of America
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Mississippi
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sofia
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Nova Scotia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Croatia
State/province [18] 0 0
Zagreb
Country [19] 0 0
Germany
State/province [19] 0 0
Achim
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Italy
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Pavia
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Italy
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Perugia
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Italy
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Roma
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Italy
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Torino
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Italy
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Udine
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Italy
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Varese
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Korea, Republic of
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Busan
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Malaysia
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Ipoh
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Malaysia
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Johor Bahru
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Malaysia
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Kuala Lumpur
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Malaysia
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Taiping
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Katowice
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Poland
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Mosina
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Romania
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Arad
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Romania
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Brasov
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Romania
State/province [45] 0 0
Bucharest
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Romania
State/province [46] 0 0
Oradea
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Romania
State/province [47] 0 0
Sibiu
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Russian Federation
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Ekaterinburg
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Singapore
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Singapore
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Spain
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Ceuta
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Spain
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Córdoba
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Spain
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Madrid
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Spain
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Zaragoza
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Aberdeen
Country [63] 0 0
United Kingdom
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Bath
Country [64] 0 0
United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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Blackpool
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United Kingdom
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Bradford
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United Kingdom
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Cannock
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Leeds
Country [70] 0 0
United Kingdom
State/province [70] 0 0
London
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Manchester
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TauRx Therapeutics Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01689246