A double-blind, placebo-controlled multicentre trial of memantine in patients with Parkinson?s disease dementia or dementia with Lewy bodies

Completed

• Conditions: Parkinson?s disease dementia or dementia with Lewy bodies; Nervous System Diseases; Dementia in other diseases classified elsewhere

• Registration Number: ISRCTN89624516
• Lead Sponsor: Stavanger Helseforskning AS (Norway)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 74

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

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 <40 ml per minute/1.73 m^2)
9. Moderate or severe heart disease (New York Heath Association [NYHA] III-IV)
10. Moderate to severe pulmonary disease
11. Moderate to severe hepatic impairment (bilirubin or transaminases >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified