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
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