Status:
COMPLETED
Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)
Lead Sponsor:
Helse Stavanger HF
Collaborating Sponsors:
King's College London
Lund University
Conditions:
Dementia Associated With Parkinson's Disease
Dementia With Lewy Bodies
Eligibility:
All Genders
Phase:
PHASE2
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00630500
Start Date
February 1 2006
End Date
March 1 2009
Last Update
July 28 2015
Active Locations (4)
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1
Stavanger University Hospital, Old Age Psychiatry Clinic
Stavanger, Norway, 4005
2
Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo
Malmo, Sweden, 20502
3
Mental Health Unit
Epping, Essex, United Kingdom, CM16 6TN
4
King's COllege London
London, London, United Kingdom, SE1 1UL