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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01689233




Registration number
NCT01689233
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 Alzheimer's Disease
Scientific title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of TRx0237 in Subjects With Mild Alzheimer's Disease
Secondary ID [1] 0 0
TRx-237-005
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 200 mg/day
Treatment: Drugs - Placebo

Experimental: TRx0237 200 mg/day -

Placebo comparator: Placebo -


Treatment: Drugs: TRx0237 200 mg/day
TRx0237 100 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 in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
Timepoint [1] 0 0
78 weeks
Primary outcome [2] 0 0
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)
Timepoint [2] 0 0
78 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
78 weeks
Secondary outcome [1] 0 0
Change from Baseline in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Timepoint [1] 0 0
78 weeks
Secondary outcome [2] 0 0
Change from Baseline in Mini-Mental Status Examination (MMSE)
Timepoint [2] 0 0
78 weeks
Secondary outcome [3] 0 0
Change from Baseline in Neuropsychiatric Inventory (NPI)
Timepoint [3] 0 0
78 weeks
Secondary outcome [4] 0 0
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [4] 0 0
78 weeks
Secondary outcome [5] 0 0
Change in expected decline of whole brain volume as measured by brain MRI
Timepoint [5] 0 0
78 weeks

Eligibility
Key inclusion criteria
* Diagnosis of all cause dementia and probable Alzheimer's disease
* Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild) and MMSE score of 20-26 (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, 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 (unless otherwise noted):

* 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 of methemoglobinemia at approved doses
* Current or prior participation in a clinical trial as follows:

* Clinical trial of a product for cognition in which the last dose was received within 90 days prior to Screening (unless confirmed to have been randomized to placebo)
* A clinical trial of a drug, biologic, 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
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
800
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Discipline of Psychiatry, University of Queensland - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Iowa
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Maryland
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Michigan
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Mississippi
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Missouri
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Utah
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United States of America
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Wisconsin
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Sint-Truiden
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Belgium
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Wilrijk
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Canada
State/province [30] 0 0
British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Croatia
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Zagreb
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Finland
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Kuopio
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Finland
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Turku
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France
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Colmar Cedex
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France
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Toulouse
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France
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Villeurbanne
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Germany
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Achim
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Germany
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Berlin
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Germany
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Leipzig
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Germany
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Rostock
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Italy
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Ancona
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Italy
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Brescia
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Italy
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Chieti Scalo
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Italy
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Genova
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Italy
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Roma
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Netherlands
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Rotterdam
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Terrassa
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United Kingdom
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Aberdeen
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United Kingdom
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Crowborough
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United Kingdom
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London
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United Kingdom
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Southampton
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United Kingdom
State/province [56] 0 0
Swindon

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/NCT01689233