A 1-Year Randomised, Double-Blind Placebo-Controlled Study to Evaluate the Effects of Memantine on Rate of Brain Atrophy in Patients with Alzheimer’s Disease

INTERVENTION: Product Name: Ebixa Product Code: Lu 00‐800 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: memantine hydrochloride CAS Number: 41100‐52‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Ebixa Product Code: Lu 00‐800 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: memantine hydrochloride CAS Number: 41100‐52‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Probable Alzheimer's Disease of moderate severity. PRIMARY OUTCOME: Main Objective: To evaluate the effects of memantine on the rate of brain atrophy in patients with probable AD over the course of one year’s treatment, using MRI technology. Primary end point(s): Rate of total brain volume loss (or rate of brain atrophy) on MRI. Secondary Objective: In addition, the study will evaluate the clinical efficacy of memantine treatment, through the use of cognitive and behavioural measures and explore associations between changes in clinical and MRI outcomes. The study will also evaluate the safety and tolerability of memantine over 1 year. INCLUSION CRITERIA: Any patient who meets all the following criteria at both the Screening and the Baseline visits is eligible for inclusion in this study: 1. Written informed consent must be obtained from the patient (or a legally acceptable representative if applicable and if different from the responsible caregiver) and the responsible caregiver, prior to the initiation of any study specific procedures (see protocol for further details on the informed consent procedure). 2. Male or female ambulatory, or ambulatory aided (i.e., walker or cane) outpatients at least 50 years of age. 3. The patient has a current diagnosis of probable Alzheimer's disease consistent with NINCDS‐ADRDA Criteria (see protocol Appendix 1). 4. The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study. 5. The patient’s MRI scan conducted at Screening is consistent with a diagnosis of proba