Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine (NCT03858270) | Clinical Trial Compass
UnknownPhase 3
Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
United States50 participantsStarted 2019-04-01
Plain-language summary
Lewy Body Dementia (LBD), is the second most common form of dementia after Alzheimer's Disease. Dementia is defined as a serious loss in cognitive ability due to damages or disease in the brain beyond what is normal aging. With Lewy Body Dementia, protein deposits, or Lewy Bodies, accumulate in nerve cells throughout the brain, affecting motor control, memory and thinking. LBD can also form with the progression of Parkinson's disease (PD). PD is a degenerative nervous system disorder that affects movement ability. Using more sensitive MRI imaging techniques the investigators are attempting to see if disease progression can be monitored more closely. At the same time, the study medication Memantine will be compared to a placebo to determine if it can be used to slow the progression of PD. The purpose of this study is to assess if disease progression can be better monitored through brain imaging and if Memantine will help slow disease progression.
Who can participate
Age range45 Years – 85 Years
SexALL
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Inclusion criteria
✓. Diagnosed with idiopathic PD for at least 2 or more years
✓. 45 to 85 years of age
✓. Have been on stable doses of anti-Parkinson medication
✓. Able to give informed consent
✓. Able to undergo brain MRI
✓. Unilateral symptoms
✓. A score of 26 or greater on the Montreal Cognitive Assessment (MOCA), a measure of a patients short-term memory recall, the ability to determine visual-spatial relationships of objects, attention, concentration, working memory, language and orientation to time and place
✓. Use of one method of medically approved contraceptive
Exclusion criteria
✕. History of any surgical intervention for treating PD (i.e. deep brain stimulation)
✕. Extreme physical disability
What they're measuring
1
Change in Rey Auditory Verbal Learning Test (RAVLT) Scores (baseline to year-1)
Timeframe: Change from baseline RAVLT at year 1
2
Change in Trail test performance time (baseline to year-1)
Timeframe: Change from baseline Trail test at year 1
3
Change in Stroop Color Word Test performance (baseline to year-1)
Timeframe: Change from baseline Stroop Color Word Test at year 1
4
Change Judgment of Line Orientation test performance score (baseline to year-1)
Timeframe: Change from baseline Judgment of Line Orientation test at year 1