Official Title: “A Double-Blind, Placebo-Controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies”

A 24-week placebo-controlled parallel group multicentre trial to study the safety and efficacy of memantine in patients with dementia associated with Parkinson's disease and dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: Memantine
  • Tablets, 5 or 10 mg, twice daily
• Drug: Placebo
  • Tablets, 5 or 10 mg, twice daily, 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Placebo Comparator: B

Primary Measures

• Clinical Global Impression of Change
  • Time Frame: Month 3 and 6 after baseline
    Safety Issue?: No

Secondary Measures

• MMSE
  • Time Frame: Month 3 and 6
    Safety Issue?: No
• Alzheimer's QUick Test
  • Time Frame: Month 3 and 6
    Safety Issue?: No
• Cognitive Drug Research test
  • Time Frame: Month 3 and 6
    Safety Issue?: No
• Neuropsychiatric Inventory
  • Time Frame: Month 3 and 6
    Safety Issue?: No
• Unified Parkinson's Disease Rating Scale, part III
  • Time Frame: Month 3 and 6
    Safety Issue?: No
• Epworth Sleep Scale
  • Time Frame: Month 3 and 6
    Safety Issue?: No
• Stavanger Sleep Scale
  • Time Frame: Month 3 and 6
    Safety Issue?: No

Inclusion Criteria:

• a diagnosis of Parkinson's disease (Larsen and Dupont, 1994) and dementia (DSM
• IV(1987; 1994), or Dementia with Lewy bodies (McKeith et al.
• Neurology 2005)
• mild-to-moderate or moderate dementia (i.e. MMSE 12-26, inclusive)
• the subject has given a written informed consent
• the subject is able and willing to comply with the study procedures and has a reliable caregiver (i.e. relative or nurse/nurse assistant who sees the patient at least weekly)

Exclusion Criteria:

• other brain disease of sufficient severity to cause dementia
• mental retardation
• terminal illness with life expectancy shorter than 6 months
• recent major changes in health status
• known epilepsy or previous convulsive seizure
• major depression
• severe dementia as defined by a Mini-mental State Examination score of 12 or lower
• moderate to severe renal impairment (i.e. serum creatinine > 1,5 upper limit normal (ULN) or creatinin clearance < 40ml/minute/1,73 m2
• moderate or severe heart disease (NYHA III-IV)
• moderate or severe pulmonal disease
• moderate to severe hepatic impairment (bilirubin or transaminases > 2 times ULN
• women of childbearing potential (i.e. not post-menopausal and not taking contraceptive
• the subjects is lactating
• any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the study physician
• known allergies to the investigational product

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stavanger University Hospital

Overall Clinical Trial Officials and Contacts

Dag Aarsland, MD, PhD Principal Investigator Stavanger University Hospital  

Overall Contact: Katja Kosssanowski, Psychol 44-207-848-8195 Katja.Kossakowski@kcl.ac.uk

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00630500

Study ID Number: MEMPDD-130206

ClinicalTrials.gov Identifier: NCT00630500

Health Authority: Norway: Norwegian Medicines Agency