Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

Conditions
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Dementia Associated With Parkinson's Disease, Dementia With Lewy Bodies

Intervention / Treatment
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* Drug: Memantine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Memantine<br>Active treatment with memantine | Drug: Memantine<br>* Tablets, 5 or 10 mg, twice daily<br>|
| Placebo Comparator: Placebo<br>Placebo matching active study drug | Drug: Placebo<br>* Tablets corresponding to 5 or 10 mg, twice daily, 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Change |  | Month 3 and 6 after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE |  | Month 3 and 6 | 
| Alzheimer's QUick Test |  | Month 3 and 6 | 
| Cognitive Drug Research test |  | Month 3 and 6 | 
| Neuropsychiatric Inventory |  | Month 3 and 6 | 
| Unified Parkinson's Disease Rating Scale, part III |  | Month 3 and 6 | 
| Epworth Sleep Scale |  | Month 3 and 6 | 
| Stavanger Sleep Scale |  | Month 3 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Memantine, Placebo-controlled, Parallel group