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CompletedPhase 4

Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies

A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

Lead sponsor

H. Lundbeck A/S

Asset

Memantine

Listed sites

1

Recruiting sites

-

Enrollment

199

actual

Study population

Lewy body dementia

Key I/E criteria

Parkinson's disease dementiaMMSE 12-24Study partner/caregiver required

Primary endpoint

No primary or secondary outcome measures are defined. This study is exploratory

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 ID11018
Eudract number2005-002038-36
NCT IDNCT00855686

Timeline

Milestones

Study start2007-01 (month precision)
Primary completion2008-12actual (month precision)
Study completion2009-01actual (month precision)
Study first posted2009-03-04estimated
Last update posted2013-09-20estimated

Assets

Drug assets

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

The study population will consist of male or female outpatients at least 50 years of age with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study

Exclusion criteria

Evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with AChEIs.

Endpoints (1)

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.

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

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.