Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each individual patient will continue for as long as the treating physician feels there is benefit to the patient. This current protocol covers each patient for 12 months in the first instance.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 30mg tid TRx0014 |
|
| 2 | Active Comparator | 60mg tid TRx0014 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRx0014 | Drug | Gelatin capsule, tid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive ability measured by the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and by the Mini-Mental State Examination (MMSE). | 0, 26 and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dementia severity assessed by the Clinical Dementia Rating - sum of the boxes (CDR-sb). | 0, 26 and 52 weeks | |
| Daily living activities assessed by the Alzheimer's Disease functional Assessment and Change Scale (ADFACS) | 0, 26 and 52 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Bentham, MRCPsych | Queen Elizabeth Psychiatric Hospital, United Kingdom | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |