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CompletedPhase 2

Open Label Study of TRx0014 in Alzheimer's Disease

An Open Label Continuation Study of the Effects of TRx0014 30 mg TID and 60 mg TID in Patients With Alzheimer's Disease

Asset

TRx0014

Listed sites

0

Recruiting sites

-

Enrollment

111

actual

Study population

Alzheimer’s disease

Key I/E criterion

-

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

NCT IDNCT00684944
Org study IDTRx-014-009

Timeline

Milestones

Study start2007-09-13actual
Study first posted2008-05-28estimated
Primary completion2010-12-02actual
Study completion2010-12-02actual
Last update posted2018-04-27actual

Assets

Drug assets

TRx0014

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•The 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. The carer must provide written consent to his or her own participation in the study.
•Patients with capacity must give written informed consent to participate in this study. Patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation.
•The patient must have been ongoing in TRx-014-001 at time of study termination

Exclusion criteria

•There are no exclusion criteria. All patients taking medication at the termination of study TRx-014-001 and who wish to participate are eligible for recruitment.

Endpoints (3)

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
2
Other (unclassified)
1

Global cognition

2 endpoints
Primary/protocol endpoint

Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE).

Time frame:0, 26 and 52 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb).

Time frame:0, 26 and 52 weeks

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

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS)

Time frame:0, 26 and 52 weeks

descriptive

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.