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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

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
Overactive Bladder

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

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

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 more

Secondary 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 more

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004

23%

Sleepiness/Sedation

10%

Headache

Tension/Inner Unrest

Reduced Salivation

Concentration Difficulties

Diminished Sexual Drive

Asthenia/Lassitude/Increased Fatigability

Constipation

Polyuria/Polydipsia

Orthostatic Dizziness

Nausea/Vomiting

Erectile Dysfunction

Failing Memory

Diarrhea

Increased Duration of Sleep

Reduced Duration of Sleep

Increased Dream Activity

Accomodation Disturbance

Increased Tendancy to Sweating

Weight Gain

Ejaculatory Dysfunction

Micturtion Disturbances

100%

80%

60%

40%

20%

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

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