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

Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease Dementia; Dementia With Lewy Bodies

Intervention: Memantine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).

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.


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- The study population will consist of male or female outpatients at least 50 years of

age with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study. Exclusion Criteria:

- Evidence of clinically significant active disease, evidence of other neurological

disorders, and current treatment with AChEIs.

Locations and Contacts

DE001, Munich 80804, Germany
Additional Information

Starting date: January 2007
Last updated: September 19, 2013

Page last updated: August 23, 2015

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