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CompletedPhase 2

TRx0014 in Patients With Mild or Moderate Alzheimer's Disease

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

Asset

TRx0014

Listed sites

0

Recruiting sites

-

Enrollment

323

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

NCT IDNCT00515333
Org study IDTRx-014-001

Timeline

Milestones

Study start2004-08 (month precision)
Study first posted2007-08-13estimated
Primary completion2007-12actual (month precision)
Study completion2007-12actual (month precision)
Last update posted2008-02-20estimated

Assets

Drug assets

TRx0014

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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.
•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

Exclusion criteria

•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.
•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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
4
Other (unclassified)
4
Behavior / neuropsychiatric
1

Global cognition

4 endpoints
Primary/protocol endpoint

Cognitive ability (ADAS-cog)

Time frame:At 24 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

Dementia severity (CDR-sb)

Time frame:At 12 and 24 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

Cognition (MMSE)

Time frame:At 12 and 24 weeks

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Cognitive function (ADAS-cog)

Time frame:At 6, 12, 18 and 24 weeks

ADAS-Cog

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Behavioural and psychological symptoms (NPI)

Time frame:At 12 and 24 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Global performance (ADCS-CGIC)

Time frame:At 12 and 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Dementia caseness (Short CAMDEX)

Time frame:At 12 and 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Daily activities of living (BADLS)

Time frame:At 12 and 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Changes in cerebral perfusion pattern (SPECT or PET)

Time frame:At baseline and between 24-26 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.