NCT00855686

Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies

A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.

Detailed description

The objective of this exploratory study is to assess the benefits of memantine compared to placebo in out-patients with a diagnosis of Parkinson's Disease Dementia or Dementia with Lewy Bodies (mild to moderate severity) over a 6-month period. This is a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study with specific cognitive (attention, executive function, visual perception and memory), behavioural, functional and global measures.

Conditions

• Parkinson's Disease Dementia
• Dementia With Lewy Bodies

Interventions

Type	Name	Description
DRUG	Memantine	20mg once daily oral dose
DRUG	Placebo	Daily oral dose

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2009-03-04
• Last updated: 2013-09-20

Locations

1 site across 1 country: Germany