Dementia, Alzheimer TypePhase 2NCT00515333
TRx0014 in Patients With Mild or Moderate Alzheimer's Disease
A Phase 2 study testing TRx0014 in people with Dementia, Alzheimer Type, run by TauRx Therapeutics Ltd.
Trial summary
The primary objective of the study is to investigate the effects of oral TRx0014 at three doses (30, 60 and 100 mg tid) compared with placebo on cognitive ability in patients with mild or moderate dementia of the Alzheimer type. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Alzheimer Type
- What is being tested?
- TRx0014
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments.
- Patients must be able to give written informed consent to participate in this study. Patients who lack capacity to consent may not be entered.
- Competent carer must be available and must provide written consent to his or her own participation in the study.
- Clinical diagnosis of dementia of the Alzheimer type determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria and a diagnosis of Probable Alzheimer's Disease determined by the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. Information to support the diagnosis will include that derived from:
- an abbreviated Cambridge Mental Disorders of the Elderly Examination (short CAMDEX) schedule, performed within six weeks prior to the baseline visit (Visit 0).
- Computerised tomography (CT) or magnetic resonance imaging (MRI), with no time limit on previous scans. In centres conducting SPECT/PET scans as part of their routine practice or as part of the study these may be used to inform the NINCDS-ADRDA diagnosis.
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- Patient must have mild or moderate dementia as determined by:
- Mini-Mental State Examination (MMSE) value at screening of between 10 and 26 inclusive.
- Clinical Dementia Rating (CDR) at screening of Stage 1 or Stage 2.
Who cannot join
- Patient has a known sensitivity to TRx0014, similar agents or any of the excipients used.
- Screening blood sample shows that the patient has glucose-6-phosphate dehydrogenase deficiency.
- Patient has known hereditary methaemoglobinaemia, has been known to have suffered an attack of acquired methaemoglobinaemia or has a blood level of methaemoglobin at screening which is above the upper limit of normal for age and laboratory.
- Patient has significant impairment of renal, hepatic or haematological function for the age of the patient.
- Patient is currently taking other anti-dementia drugs (e.g. memantine, cholinesterase inhibitors) or has taken these within the previous six weeks.
- It is anticipated that there will be a definite indication for the commencement of other licensed anti-dementia drug treatment within the 24 week treatment period of the trial.
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- Patient has started taking other medication known to have an effect on mood or cognition (e.g. anticholinergics, hypnotics, sedatives, anxiolytics, neuroleptics, antidepressants, antiepileptics) within the previous six weeks; or has changed their dose of these medications within the previous six weeks.
- Patient has started taking 'alternative therapy' for AD e.g. vitamin E, folic acid, hormone replacement therapy (HRT), ginkgo biloba within the previous six weeks; or has changed their dose of these treatments within the previous six weeks.
- Patient is receiving warfarin or digitalis or any other medication that has a narrow margin between effective dose and toxic dose or between effective dose and ineffective dose, where the subject would be at risk if the levels were elevated or fell due to interaction with TRx0014.
- Patients who are unlikely to comply with trial visit schedule or with trial medication.
- Significant intercurrent illness which may compromise safety of the patient/validity of the data.
- Females with the potential of childbearing and are not using adequate contraception or females who are breastfeeding.
- Patients with a history of alcohol and/or drug abuse, defined as meeting DSM-IV criteria for substance dependence. This applies to alcohol and/or any illicit drug, including cannabis within the last six months.
- Patient has participated in a clinical investigation of a medication or device within the previous three months.
About this study
Official title: An Exploratory Placebo-Controlled, Dose-Ranging Study of the Effects of TRx0014 30 MG TID, 60 MG TID AND 100 MG TID in Patients With Mild or Moderate Dementia of the Alzheimer Type
The primary objective of the study is to investigate the effects of oral TRx0014 at three doses (30, 60 and 100 mg tid) compared with placebo on cognitive ability in patients with mild or moderate dementia of the Alzheimer type. Cognitive ability will be measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog). The primary evaluation will be made at 24 weeks.
- Conditions
- Dementia, Alzheimer Type
- Being tested
- TRx0014, Placebo
- Keywords
- Alzheimer, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRx0014Drug
Hard capsule; 60 milligrams; t.i.d.
TRx0014Drug
Hard capsule; 30 milligrams; t.i.d.
PlaceboDrug
Hard capsule; 0 milligrams; t.i.d.
TRx0014Drug
Hard capsule, 100 milligrams, t.i.d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo: 0 milligrams; t.i.d. Receives: Drug: Placebo |
| 2 | Active comparator | Treatment group: 30 milligrams; t.i.d. Receives: Drug: TRx0014 |
| 3 | Active comparator | Treatment group: 60 milligrams; t.i.d. Receives: Drug: TRx0014 |
| 4 | Active comparator | Treatment group: 100 milligrams; t.i.d. Receives: Drug: TRx0014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive ability (ADAS-cog)
Measured: At 24 weeks
Secondary outcomes (8)
Behavioural and psychological symptoms (NPI)
Measured: At 12 and 24 weeks
Global performance (ADCS-CGIC)
Measured: At 12 and 24 weeks
Dementia severity (CDR-sb)
Measured: At 12 and 24 weeks
Cognition (MMSE)
Measured: At 12 and 24 weeks
Dementia caseness (Short CAMDEX)
Measured: At 12 and 24 weeks
Cognitive function (ADAS-cog)
Measured: At 6, 12, 18 and 24 weeks
Daily activities of living (BADLS)
Measured: At 12 and 24 weeks
Changes in cerebral perfusion pattern (SPECT or PET)
Measured: At baseline and between 24-26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startAug 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia, Alzheimer TypeStudies 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
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- TauRx Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claude M Wischik, MBChB, Study chair, TauRx Therapeutics LtdPeter Bentham, MBChB, Principal investigator, Queen Elizabeth Psychiatric Hospital, Birmingham, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515333
- Sponsor's protocol ID
- TRx-014-001
- Status last verified
- Feb 2008
- First submitted
- 10 Aug 2007
- Last updated
- 20 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Wischik CM, Staff RT, Wischik DJ, Bentham P, Murray AD, Storey JM, Kook KA, Harrington CR. Tau aggregation inhibitor therapy: an exploratory phase 2 study in mild or moderate Alzheimer's disease. J Alzheimers Dis. 2015;44(2):705-20. doi: 10.3233/JAD-142874.
PubMed 25550228
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Placebo-Controlled, Dose-Ranging Study of the Effects of TRx0014 30 MG TID, 60 MG TID AND 100 MG TID in Patients With Mild or Moderate Dementia of the Alzheimer Type
- ClinicalTrials.gov ID
- NCT00515333
- Acronym / sponsor ID
- TRx-014-001
- Conditions
- Dementia, Alzheimer Type
- Keywords
- Alzheimer, Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- TauRx Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to investigate the effects of oral TRx0014 at three doses (30, 60 and 100 mg tid) compared with placebo on cognitive ability in patients with mild or moderate dementia of the Alzheimer type. Cognitive ability will be measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog). The primary evaluation will be made at 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo: 0 milligrams; t.i.d. |
| 2 | Active comparator | Drug: TRx0014Treatment group: 30 milligrams; t.i.d. |
| 3 | Active comparator | Drug: TRx0014Treatment group: 60 milligrams; t.i.d. |
| 4 | Active comparator | Drug: TRx0014Treatment group: 100 milligrams; t.i.d. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments.
- Patients must be able to give written informed consent to participate in this study. Patients who lack capacity to consent may not be entered.
- Competent carer must be available and must provide written consent to his or her own participation in the study.
- Clinical diagnosis of dementia of the Alzheimer type determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria and a diagnosis of Probable Alzheimer's Disease determined by the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. Information to support the diagnosis will include that derived from:
- Patient must have mild or moderate dementia as determined by:
Key exclusion criteria (14 listed)
- Patient has a known sensitivity to TRx0014, similar agents or any of the excipients used.
- Screening blood sample shows that the patient has glucose-6-phosphate dehydrogenase deficiency.
- Patient has known hereditary methaemoglobinaemia, has been known to have suffered an attack of acquired methaemoglobinaemia or has a blood level of methaemoglobin at screening which is above the upper limit of normal for age and laboratory.
- Patient has significant impairment of renal, hepatic or haematological function for the age of the patient.
- Patient is currently taking other anti-dementia drugs (e.g. memantine, cholinesterase inhibitors) or has taken these within the previous six weeks.
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 |
|---|---|---|
| TRx0014Hard capsule; 60 milligrams; t.i.d. | Drug | 3 |
| TRx0014Hard capsule; 30 milligrams; t.i.d. | Drug | 2 |
| PlaceboHard capsule; 0 milligrams; t.i.d. | Drug | 1 |
| TRx0014Hard capsule, 100 milligrams, t.i.d. | Drug | 4 |
Primary outcome
Cognitive ability (ADAS-cog)
Time frame: At 24 weeks
8 secondary outcomes
Behavioural and psychological symptoms (NPI)
Time frame: At 12 and 24 weeks
Global performance (ADCS-CGIC)
Time frame: At 12 and 24 weeks
Dementia severity (CDR-sb)
Time frame: At 12 and 24 weeks
Cognition (MMSE)
Time frame: At 12 and 24 weeks
Dementia caseness (Short CAMDEX)
Time frame: At 12 and 24 weeks
Cognitive function (ADAS-cog)
Time frame: At 6, 12, 18 and 24 weeks
Daily activities of living (BADLS)
Time frame: At 12 and 24 weeks
Changes in cerebral perfusion pattern (SPECT or PET)
Time frame: At baseline and between 24-26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2008.
- Derived from this study: PubMed 25550228Wischik CM, Staff RT, Wischik DJ, Bentham P, Murray AD, Storey JM, Kook KA, Harrington CR. Tau aggregation inhibitor therapy: an exploratory phase 2 study in mild or moderate Alzheimer's disease. J Alzheimers Dis. 2015;44(2):705-20. doi: 10.3233/JAD-142874.
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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.
Claude M Wischik, MBChB study chair
TauRx Therapeutics Ltd
Peter Bentham, MBChB principal investigator
Queen Elizabeth Psychiatric Hospital, Birmingham, United Kingdom
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRx0014 in people with Dementia, Alzheimer Type, run by TauRx Therapeutics Ltd.
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 9 inclusion and 14 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: finished, as of the sponsor's last update on 20 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive ability (ADAS-cog) (time frame: At 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00515333, which also lists 1 linked publication.
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 20 Feb 2008.