Parkinson?s disease dementia or dementia with Lewy bodies Nervous System Diseases Dementia in other diseases classified elsewhere
Conditions
Interventions
Memantine versus placebo
Added as of 24/09/2008: Recruitment has been completed. Seventy-five patients were randomised.
Sponsors
Stavanger Helseforskning AS (Norway)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of PD (Larsen, Dupont et al. 1994) and PD-dementia (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition [DSM IV] (1987, 1994) or DLB (McKeith et al. Neurol 2005) 2. Mild-to-moderate or moderate dementia (i.e. mini mental state examination MMSE 12-26, inclusive) 3. The subject has given a written informed consent 4. 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
Exclusion criteria: 1. Other brain disease of sufficient severity to cause dementia 2. Mental retardation 3. Terminal illness with life expectancy shorter than six months 4. Recent major changes in health status 5. Known epilepsy or previous convulsive seizure 6. Major depression 7. Severe dementia as defined by MMSE score of 12 or lower 8. Moderate to severe renal impairment (i.e. serum creatinine >1.5 upper limit normal (ULN) or creatinine clearance 2 times ULN) 12. Women of childbearing potential (i.e. not post-menopausal and not taking contraceptive) 13. The subjects is lactating 14. Any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the study physician 15. Known allergies to the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinician's global impression of change (CGIC) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mini-mental state examination 2. Alzheimer?s quick test 3. Cognitive drug research test 4. Neuropsychiatric inventory 5. Unified Parkinson?s disease rating scale 6. Epworth sleepiness scale and Stavanger scale 7. Activities of daily living 8. Disability assessment for dementia 9. Quality of life assessment 10. Mayo fluctuation scale | — |
Countries
Norway, Sweden, United Kingdom
Outcome results
None listed