Conditions: Dementia of the Alzheimer's Type
Keywords: memantine Alzheimer's disease moderate to severe Alzheimer's disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 677
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).

Detailed description:
Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver. The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.

Arms:
arm 1: Oral administration, once daily. arm 2: 28mg, once daily. Oral administration for 24 weeks.

Interventions: intervention 1: memantine ER intervention 2: Placebo
Intervention descriptions: intervention 1: 28mg(7mg capsules) once daily and oral administration for 24 weeks. intervention 2: Matching placebo oral administration once daily.

Protocol document: