Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)

Dementia With Lewy Bodies Clinical Trial

— MEMPDD  

Official title:

A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630500
• Other study ID #: MEMPDD-130206
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2008
• Last updated: July 27, 2015
• Start date: February 2006
• Est. completion date: March 2009

Study information

• Verified date: February 2009
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Dementia Associated With Parkinson's Disease
• Dementia With Lewy Bodies
• Lewy Body Disease
• Parkinson Disease

Intervention

Drug:
• Memantine
Tablets, 5 or 10 mg, twice daily
• Placebo
Tablets corresponding to 5 or 10 mg, twice daily, 6 months

Locations

Country	Name	City	State
Norway	Stavanger University Hospital, Old Age Psychiatry Clinic	Stavanger
Sweden	Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo	Malmo
United Kingdom	Mental Health Unit	Epping	Essex
United Kingdom	King's COllege London	London

Sponsors (3)

Lead Sponsor	Collaborator
Helse Stavanger HF	King's College London, Lund University

Countries where clinical trial is conducted

Norway,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression of Change		Month 3 and 6 after baseline	No
Secondary	MMSE		Month 3 and 6	No
Secondary	Alzheimer's QUick Test		Month 3 and 6	No
Secondary	Cognitive Drug Research test		Month 3 and 6	No
Secondary	Neuropsychiatric Inventory		Month 3 and 6	No
Secondary	Unified Parkinson's Disease Rating Scale, part III		Month 3 and 6	No
Secondary	Epworth Sleep Scale		Month 3 and 6	No
Secondary	Stavanger Sleep Scale		Month 3 and 6	No