Clinical trial NCT00630500: Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)
Official title: A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia Associated With Parkinson's Disease
Dementia With Lewy Bodies
Keywords: Dementia associated with Parkinson's disease
Dementia with Lewy bodies
Memantine
Placebo-controlled
Parallel group
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: King's College London
name: Lund University
First posted: 2008-03-07
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impression of Change
timeFrame: Month 3 and 6 after baseline
Secondary outcomes:
measure: MMSE
timeFrame: Month 3 and 6
measure: Alzheimer's QUick Test
timeFrame: Month 3 and 6
measure: Cognitive Drug Research test
timeFrame: Month 3 and 6
measure: Neuropsychiatric Inventory
timeFrame: Month 3 and 6
measure: Unified Parkinson's Disease Rating Scale, part III
timeFrame: Month 3 and 6
measure: Epworth Sleep Scale
timeFrame: Month 3 and 6
measure: Stavanger Sleep Scale
timeFrame: Month 3 and 6
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Old Age Psychiatry Clinic
city: Malmo
country: Sweden
facility: Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo
city: Epping
country: United Kingdom
facility: Mental Health Unit
state: Essex
city: London
country: United Kingdom
facility: King's COllege London
Study officials:
affiliation: Helse Stavanger HF
name: Dag Aarsland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: