Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)
Information source: Helse Stavanger HF
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dementia Associated With Parkinson's Disease; Dementia With Lewy Bodies
Intervention: Memantine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Helse Stavanger HF Official(s) and/or principal investigator(s): Dag Aarsland, MD, PhD, Principal Investigator, Affiliation: Helse Stavanger HF
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.
Clinical Details
Official title: A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical Global Impression of Change
Secondary outcome: MMSEAlzheimer's QUick Test Cognitive Drug Research test Neuropsychiatric Inventory Unified Parkinson's Disease Rating Scale, part III Epworth Sleep Scale Stavanger Sleep Scale
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Stavanger University Hospital, Old Age Psychiatry Clinic, Stavanger 4005, Norway
Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo, Malmo 20502, Sweden
King's COllege London, London SE1 1UL, United Kingdom
Mental Health Unit, Epping, Essex CM16 6TN, United Kingdom
Additional Information
Starting date: February 2006
Last updated: July 27, 2015
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