← Trials/Trial dossier/NCT00294554
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
Lead sponsor
Asset
Memantine
Listed sites
1
Recruiting sites
-
Enrollment
20
actual
Study population
Lewy body dementia
Key I/E criteria
•Study partner/caregiver required•Background AD symptomatic therapy, if used: stable ≥2 months
Primary endpoints
•Dementia Rating Scale (DRS) Memory Subscore•CIBIC-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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsChange in Dementia Rating Scale (DRS) Memory Subscore
Time frame:change from baseline to 24 weeks
change from baseline, improvement
Change in Dementia Rating Scale (DRS) Memory Subscore
Time frame:change from baseline to 24 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | Reported bounds |
|---|---|---|
| Active Memantinen=10 Participants | 1.6 | --0.13 - 3.33 |
| Placebo Oral Tabletn=10 Participants | -1.4 | --3.19 - 0.39 |
Caregiver / quality of life
2 endpointsCIBIC-Plus Score
Time frame:24 weeks
change from baseline, improvement
CIBIC-Plus Score
Time frame:24 weeks
change from baseline, improvement
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Active MemantineVery Much Improvedn=10 Participants | 1 | - |
| Much Improvedn=10 Participants | 5 | - |
| Minimally Improvedn=10 Participants | 2 | - |
| No Changen=10 Participants | 0 | - |
| Minimally Worsen=10 Participants | 2 | - |
| Much Worsen=10 Participants | 0 | - |
| Very Much Worsen=10 Participants | 0 | - |
| Placebo Oral TabletVery Much Improvedn=10 Participants | 0 | - |
| Much Improvedn=10 Participants | 2 | - |
| Minimally Improvedn=10 Participants | 1 | - |
| No Changen=10 Participants | 3 | - |
| Minimally Worsen=10 Participants | 2 | - |
| Much Worsen=10 Participants | 2 | - |
| Very Much Worsen=10 Participants | 0 | - |
Provenance
Sources
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.