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NMDA receptor antagonist
Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
Phase 3
Waitlist Available
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline ravlt at year 1
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Summary
This trial is testing Memantine, a medication that may help slow down the worsening of symptoms in people with Parkinson's disease and Lewy Body Dementia. The study focuses on patients with these conditions because they experience significant declines in movement and thinking abilities. Memantine works by protecting brain cells from damage.
Eligible Conditions
- Parkinson's Disease
- Dementia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline ravlt at year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline ravlt at year 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change Judgment of Line Orientation test performance score (baseline to year-1)
Change in Rey Auditory Verbal Learning Test (RAVLT) Scores (baseline to year-1)
Change in Stroop Color Word Test performance (baseline to year-1)
+1 moreSecondary study objectives
Change in cortical thickness (Cth), as measured by MRI T1 sequence, in multiple brain regions (mentioned in outcome #5), baseline to year-1.
Change in fractional anisotropy (FA), as measured by diffusion tensor imaging (DTI) sequence, in multiple brain regions (mentioned in outcome #5), baseline to year-1.
Change in the Intracellular volume (ICV), as measured by MRI NODDI sequence, in multiple brain regions, baseline to year-1.
+1 moreSide effects data
From 2019 Phase 4 trial • 115 Patients • NCT0190200423%
Sleepiness/Sedation
10%
Headache
8%
Tension/Inner Unrest
8%
Reduced Salivation
8%
Concentration Difficulties
8%
Diminished Sexual Drive
6%
Asthenia/Lassitude/Increased Fatigability
6%
Constipation
6%
Polyuria/Polydipsia
6%
Orthostatic Dizziness
4%
Nausea/Vomiting
4%
Erectile Dysfunction
4%
Failing Memory
2%
Diarrhea
2%
Increased Duration of Sleep
2%
Reduced Duration of Sleep
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Weight Gain
2%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MemantineExperimental Treatment1 Intervention
Memantine will be started at 10 mg tablet once/day for a week at bedtime. After one week Memantine will be administered at 10 mg tablet twice/day for 51 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be started at 10 mg tablet once/day for a week at bedtime. After one week placebo will be administered at 10 mg tablet twice/day for 51 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine
FDA approved
Find a Location
Who is running the clinical trial?
Wayne State UniversityLead Sponsor
314 Previous Clinical Trials
110,847 Total Patients Enrolled