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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00630500

Acronym

MEMPDD

Enrollment

Registered

2008-03-07

Start date

2006-02-28

Completion date

2009-03-31

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Memantine, Placebo-controlled, Parallel group

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.

Interventions

DRUGMemantine

Tablets, 5 or 10 mg, twice daily

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical Global Impression of Change	Month 3 and 6 after baseline

Secondary

Measure	Time frame
Alzheimer's QUick Test	Month 3 and 6
Cognitive Drug Research test	Month 3 and 6
Neuropsychiatric Inventory	Month 3 and 6
MMSE	Month 3 and 6
Epworth Sleep Scale	Month 3 and 6
Stavanger Sleep Scale	Month 3 and 6
Unified Parkinson's Disease Rating Scale, part III	Month 3 and 6

Countries

Norway, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026