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CompletedPhase NAResults posted

Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia

Double-Blind Placebo-Controlled Trial of Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia

Asset

Memantine

Listed sites

1

Recruiting sites

-

Enrollment

20

actual

Study population

Lewy body dementia

Key I/E criteria

Study partner/caregiver requiredBackground AD symptomatic therapy, if used: stable ≥2 months

Primary endpoints

Dementia Rating Scale (DRS) Memory SubscoreCIBIC-Plus Score

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 ID04-08-20-03
NCT IDNCT00294554

Timeline

Milestones

Study first posted2006-02-22estimated
Study start2006-04 (month precision)
Primary completion2008-09actual (month precision)
Study completion2008-12actual (month precision)
Last update posted2017-09-12actual
Results first posted2017-09-12actual

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

1. Diagnosis of idiopathic PD, as defined by UK Brain Bank Criteria.

2. Age onset of PD > 35 years old

3. Adult men and women, current age > 50 years

4. English speaking

5. Any race or ethnic background.

6. Hoehn and Yahr Stage I-V, provided able to participate verbally in clinical assessments and travel to clinic.

7. Diagnosis of dementia secondary to PD, as defined by DSM-IV-TR.

8. Stable medical health

9. Taking stable doses for 2 months of non-excluded medications.

10. Outpatient status (may be residing in a long-term care facility).

11. Able to attend all study visits with an informed caregiver/partner who is willing to provide information on the patient's clinical status and response to treatment.

12. Presence of an informed caregiver willing to take part in weekly phone call follow-up calls for the duration of study enrollment.

13. Provision of informed consent by patient and caregiver and/or legal guardian.

14. On stable antiparkinsonian therapy for 2 months.

15. If history of major depression or anxiety disorder, must have stable symptoms and be on stable therapy for 2 months.

16. If taking antipsychotic medication, must be on stable therapy for 2 months.

17. If taking nonsteroidal anti-inflammatory medication, selegiline, or estrogen, must be on a stable dose for 30 days before study entry.

18. If taking cholinesterase inhibitors, must be on for at least 6 months and a stable dose for 2 months before randomization

Exclusion criteria

1. History or evidence of neurodegenerative disorder other than PD.

2. Meets clinical criteria for Dementia with Lewy Bodies.

3. History or current evidence of epilepsy.

4. Participation in another investigational drug trial within 2 months of screening.

5. Treatment with memantine within 60 days of screening.

6. Current symptomatic Major Depressive Disorder, as based on Hamilton Depression Rating Scale Score > 17.

7. Current clinically significant hepatic, kidney disease, gastrointestinal, endocrine, or cardiovascular disease, including evidence of second or third degree heart block. [Note, patients with controlled hypertension (supine diastolic BP<95 mm Hg), complete or partial right bundle branch block, pacemakers, or deep brain stimulators may be included.].

Endpoints (4)

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

Memory
2
Caregiver / quality of life
2

Memory

2 endpoints
Primary/protocol endpoint

Change in Dementia Rating Scale (DRS) Memory Subscore

Time frame:change from baseline to 24 weeks

change from baseline, improvement

Primary/registry result

Change in Dementia Rating Scale (DRS) Memory Subscore

Time frame:change from baseline to 24 weeks

change from baseline, improvement

Posted result

GroupValue (mean), units on a scaleReported bounds
Active Memantinen=10 Participants1.6--0.13 - 3.33
Placebo Oral Tabletn=10 Participants-1.4--3.19 - 0.39

Caregiver / quality of life

2 endpoints
Primary/protocol endpoint

CIBIC-Plus Score

Time frame:24 weeks

change from baseline, improvement

Primary/registry result

CIBIC-Plus Score

Time frame:24 weeks

change from baseline, improvement

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Active MemantineVery Much Improvedn=10 Participants1-
Much Improvedn=10 Participants5-
Minimally Improvedn=10 Participants2-
No Changen=10 Participants0-
Minimally Worsen=10 Participants2-
Much Worsen=10 Participants0-
Very Much Worsen=10 Participants0-
Placebo Oral TabletVery Much Improvedn=10 Participants0-
Much Improvedn=10 Participants2-
Minimally Improvedn=10 Participants1-
No Changen=10 Participants3-
Minimally Worsen=10 Participants2-
Much Worsen=10 Participants2-
Very Much Worsen=10 Participants0-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.