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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855686
First Posted: March 4, 2009
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lundbeck A/S
March 3, 2009
March 4, 2009
September 20, 2013
January 2007
December 2008   (Final data collection date for primary outcome measure)
No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
Same as current
Complete list of historical versions of study NCT00855686 on ClinicalTrials.gov Archive Site
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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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Parkinson's Disease Dementia
  • Dementia With Lewy Bodies
  • Drug: Memantine
    20mg once daily oral dose
    Other Name: Ebixa®
  • Drug: Placebo
    Daily oral dose
  • Experimental: Memantine
    Intervention: Drug: Memantine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Emre M, Tsolaki M, Bonuccelli U, Destée A, Tolosa E, Kutzelnigg A, Ceballos-Baumann A, Zdravkovic S, Bladström A, Jones R; 11018 Study Investigators. Memantine for patients with Parkinson's disease dementia or dementia with Lewy bodies: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Oct;9(10):969-77. doi: 10.1016/S1474-4422(10)70194-0. Epub 2010 Aug 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
January 2009
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00855686
11018
2005-002038-36 ( EudraCT Number )
No
Not Provided
Not Provided
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP