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NMDA receptor antagonist

Memantine for Parkinson's Disease

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
Diagnosed with idiopathic PD for at least 2 or more years
Have been on stable doses of anti-Parkinson medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline ravlt at year 1
Awards & highlights

Study Summary

This trial is studying how well memantine works in slowing down the progression of Lewy Body Dementia (LBD) by using MRI brain imaging and comparing it to a placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with Parkinson's disease that has no known cause for at least two years.
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You have been taking the same amount of medication for Parkinson's disease for a while now.
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You are able to have an MRI of your brain.
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You are experiencing symptoms on only one side of your body.
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You must use a medically-approved form of birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline ravlt at year 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline ravlt at year 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004
23%
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

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
307 Previous Clinical Trials
108,679 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do elderly patients fit the age criteria for this clinical trial?

"The guidelines for who can participate in this clinical trial state that the minimum age is 45 and the maximum age is 85."

Answered by AI

Could I potentially take part in this research?

"This study, which is seeking 50 participants that suffer from parkinson's disease, has specific inclusion criteria. Most notably, potential patients must be between 45 and 85 years old, have been diagnosed for at least 2 years, and be able to give informed consent."

Answered by AI

What is the FDA's current stance on Memantine?

"Memantine's Phase 3 status indicates that, while there is data supporting its efficacy, there are also multiple rounds of data attesting to the medication's safety. Therefore, it received a score of 3."

Answered by AI

How many individuals have signed up for this experiment?

"That is right, the clinical trial is still looking for participants. According to the information on clinicaltrials.gov, the study was posted on April 1st, 2019 and updated on June 29th, 2020. The research team wants to enroll 50 individuals at a single site."

Answered by AI

Why was this research project undertaken?

"The primary outcome of this study is to evaluate the Change from baseline Trail test at year 1 time frame. The secondary outcomes include the Change in Intracellular volume (ICV), as measured by MRI NODDI sequence, in multiple brain regions, defined as ICV component is calculated from the NODDI MRI, using available software, for dorsolateral prefrontal cortex, precuneous, anterior cingulate, posterior cingulate, hippocampus, entorhinal cortex, thalamus, caudate, putamen, association visual cortex and primary visual cortex. The change in ICV fro each region will be"

Answered by AI

Can new patients still join this clinical trial?

"Yes, as of today this clinical trial is still recruiting patients. The original posting was on April 1st, 2019 with the latest update being June 29th, 2020."

Answered by AI

What is the research history of Memantine?

"There are currently 26 different ongoing clinical trials studying the effects of memantine. Most of these studies are Phase 3 trials, which means that there is some evidence supporting efficacy. 11 out of the 26 total trials are in their final stage. The majority of these studies originate from Geneva, Illinois; however, there are 290 locations spread across the globe conducting research on memantine."

Answered by AI
~8 spots leftby Mar 2025