Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease TRx0237 Safety Study AD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: TRx0237 intervention 2: Placebo
Intervention descriptions: intervention 1: TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks intervention 2: Placebo tablets will be administered twice daily (b.i.d.) for 4 weeks. The placebo tablets include 4 mg of TRx0237 as a urinary and faecal colourant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.

Protocol document: