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

NCT ID: NCT00630500

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-03-31

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. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo.

Conditions

Dementia Associated With Parkinson's Disease; Dementia With Lewy Bodies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Memantine

Active treatment with memantine

Group Type: ACTIVE_COMPARATOR

Memantine

Intervention Type: DRUG

Tablets, 5 or 10 mg, twice daily

Placebo

Placebo matching active study drug

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets corresponding to 5 or 10 mg, twice daily, 6 months

Interventions

Memantine

Tablets, 5 or 10 mg, twice daily

Intervention Type: DRUG

Placebo

Tablets corresponding to 5 or 10 mg, twice daily, 6 months

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dag Aarsland, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

Stavanger University Hospital, Old Age Psychiatry Clinic

Stavanger, , Norway

Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo

Malmo, , Sweden

Mental Health Unit

Epping, Essex, United Kingdom

King's COllege London

London, London, United Kingdom

Countries

Norway; Sweden; United Kingdom

Other Identifiers

MEMPDD-130206

Identifier Type: -

Identifier Source: org_study_id