Alzheimer's Disease
Conditions
Brief summary
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.
Interventions
DRUGTRx0014
Gelatin capsule, tid
Sponsors
TauRx Therapeutics Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Outcome results
None listed