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

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

Sponsors

Lead sponsor: Helse Stavanger HF

Collaborator: King's College London
Lund University

Source Helse Stavanger HF
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.

Overall Status Completed
Start Date February 2006
Completion Date March 2009
Primary Completion Date February 2009
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical Global Impression of Change Month 3 and 6 after baseline
Secondary Outcome
Measure Time Frame
MMSE Month 3 and 6
Alzheimer's QUick Test Month 3 and 6
Cognitive Drug Research test Month 3 and 6
Neuropsychiatric Inventory Month 3 and 6
Unified Parkinson's Disease Rating Scale, part III Month 3 and 6
Epworth Sleep Scale Month 3 and 6
Stavanger Sleep Scale Month 3 and 6
Enrollment 75
Condition
Intervention

Intervention type: Drug

Intervention name: Memantine

Description: Tablets, 5 or 10 mg, twice daily

Arm group label: Memantine

Intervention type: Drug

Intervention name: Placebo

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

Arm group label: Placebo

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Dag Aarsland, MD, PhD Principal Investigator Helse Stavanger HF
Location
facility
Stavanger University Hospital, Old Age Psychiatry Clinic | Stavanger, 4005, Norway
Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo | Malmo, 20502, Sweden
Mental Health Unit | Epping, Essex, CM16 6TN, United Kingdom
King's COllege London | London, SE1 1UL, United Kingdom
Location Countries

Norway

Sweden

United Kingdom

Verification Date

February 2009

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Memantine

Arm group type: Active Comparator

Description: Active treatment with memantine

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Placebo matching active study drug

Acronym MEMPDD
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov