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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Safety parameters include adverse events, vital signs, methemoglobin and oxygen saturation, physical and neurological examinations, laboratory tests (hematology, serum chemistry, and urinalysis), electrocardiograms, potential for serotonin toxicity, brain magnetic resonance imaging (MRI), and potential for suicide or self-harm.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Swindon

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment
of subjects with mild Alzheimer's Disease.
Trial website
https://clinicaltrials.gov/show/NCT01689233
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
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Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications