Alzheimer's DiseasePhase 2NCT01626391
Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease
A Phase 2 study testing TRx0237 in people with Alzheimer's Disease, run by TauRx Therapeutics Ltd at 12 sites in 2 countries.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- TRx0237
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Sep 2012to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of all cause dementia and probable Alzheimer's disease (AD)
- Mini-Mental State Examination (MMSE) score of 14-26 (inclusive)
- Cognitive impairment present for at least 6 months
- Age ≤90 years
- Modified Hachinski ischaemic score of ≤4
- Females, if of childbearing potential, must use adequate contraception and maintain this use throughout participation in the study
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- Patient is able to read, understand, and provide written informed consent
- Has one or more identified caregivers who are able to verify daily compliance with study drug and provide information on safety and tolerability; the caregiver(s) must also give consent to participate
- Currently taking an taking an acetylcholinesterase inhibitor and/or memantine; 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
Who cannot join
- Significant central nervous system disorder other than Alzheimer's disease
- Patients in whom baseline MRI is contraindicated such as metal implants in head (except dental), pacemaker, and cochlear implant
- Significant focal or intracranial pathology that would lead to a diagnosis other than probable Alzheimer's disease
- Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness
- Epilepsy
- Major depressive disorder, schizophrenia or other psychotic disorders, bipolar disorder, substance (including alcohol) related disorders
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- Resides in a hospital or continuous care facility
- History of swallowing difficulties
- Pregnant or breastfeeding
- 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
- Pre-existing or current signs or symptoms of respiratory failure
- Concurrent acute or chronic clinically significant immunologic, renal, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease
- Prior intolerance to methylthioninium-containing drug or any of the excipients
- Treatment currently or within 3 months before Baseline with any of the following medications (unless otherwise noted):
- Tacrine
- Anxiolytics and/or sedatives/hypnotics (exceptions: sedation for MRI or occasional short-acting benzodiazepines, chloral hydrate, or zolpidem as needed at bedtime)
- Antipsychotics (clozapine, chlorpromazine, thioridazine, or ziprasidone)
- Carbamazepine
- Drugs associated with methaemoglobinaemia (e.g., dapsone, local anesthetics such as benzocaine used chronically, primaquine and related antimalarials, sulfonamides)
- Warfarin (and other Coumadin derivates such as phenprocoumon)
- Current or prior participation in a clinical trial of a drug, biologic, or device in which the last dose was received within 28 days prior to Baseline
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United Kingdom8 sites
Study site
Birmingham
Study site
Bradford
Study site
Crowborough
Study site
Duston
Study site
Oxford
Study site
Saint Leonards-on-Sea
Study site
Sheffield
Study site
Staffordshire
Germany4 sites
Study site
Achim
Study site
Berlin
Study site
Leipzig
Study site
München
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy
The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- TRx0237, Placebo
- Keywords
- Alzheimer's Disease, TRx0237, Safety Study, AD
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRx0237Drug
TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks
PlaceboDrug
Placebo tablets will be administered twice daily (b.i.d.) for 4 weeks. The placebo tablets include 4 mg of TRx0237 as a urinary and faecal colourant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.
| Study group | Role | What they receive |
|---|---|---|
| TRx0237 | Experimental | Not described Receives: Drug: TRx0237 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine
This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: This study has been terminated for administrative reasons only.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- TauRx Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Dale, MD, Principal investigator, MAC Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626391
- Sponsor's protocol ID
- TRx-237-008
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2012
- Last updated
- 11 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy
- ClinicalTrials.gov ID
- NCT01626391
- Acronym / sponsor ID
- TRx-237-008
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, TRx0237, Safety Study, AD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated for administrative reasons only.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- TauRx Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Jun 2012 (estimated)
- Results
- Posted 11 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRx0237 | Experimental | Drug: TRx0237 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical diagnosis of all cause dementia and probable Alzheimer's disease (AD)
- Mini-Mental State Examination (MMSE) score of 14-26 (inclusive)
- Cognitive impairment present for at least 6 months
- Age ≤90 years
- Modified Hachinski ischaemic score of ≤4
Key exclusion criteria (23 listed)
- Significant central nervous system disorder other than Alzheimer's disease
- Patients in whom baseline MRI is contraindicated such as metal implants in head (except dental), pacemaker, and cochlear implant
- Significant focal or intracranial pathology that would lead to a diagnosis other than probable Alzheimer's disease
- Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRx0237TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks | Drug | TRx0237 |
| PlaceboPlacebo tablets will be administered twice daily (b.i.d.) for 4 weeks. The placebo tablets include 4 mg of TRx0237 as a urinary and faecal colourant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237. | Drug | Placebo |
Primary outcome
Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine
Time frame: 8 weeks
This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Dale, MD principal investigator
MAC Clinical Research
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRx0237 in people with Alzheimer's Disease, run by TauRx Therapeutics Ltd at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.