MEMPDD

CompletedPhase 2

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

Lead sponsor

Helse Stavanger HF

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•MMSE 12-26•Study partner/caregiver required

Primary endpoint

•Clinical Global Impression of Change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDMEMPDD-130206

NCT IDNCT00630500

Timeline

Milestones

Study start2006-02 (month precision)

Study first posted2008-03-07estimated

Primary completion2009-02actual (month precision)

Study completion2009-03actual (month precision)

Last update posted2015-07-28estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

Other clinical outcomes

Global cognition

1 endpoint

Secondary/protocol endpoint

MMSE

Time frame:Month 3 and 6

Mini-Mental State Examination (MMSE)

descriptive

Behavior / neuropsychiatric

3 endpoints

Secondary/protocol endpoint

Neuropsychiatric Inventory

Time frame:Month 3 and 6

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Epworth Sleep Scale

Time frame:Month 3 and 6

descriptive

Secondary/protocol endpoint

Stavanger Sleep Scale

Time frame:Month 3 and 6

descriptive

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Clinical Global Impression of Change

Time frame:Month 3 and 6 after baseline

descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Alzheimer's QUick Test

Time frame:Month 3 and 6

descriptive

Secondary/protocol endpoint/low confidence

Cognitive Drug Research test

Time frame:Month 3 and 6

descriptive

Secondary/protocol endpoint/low confidence

Unified Parkinson's Disease Rating Scale, part III

Time frame:Month 3 and 6

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.