Clinical trial NCT03858270: Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
Official title: Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Parkinson Disease
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with idiopathic PD for at least 2 or more years
2. 45 to 85 years of age
3. Have been on stable doses of anti-Parkinson medication
4. Able to give informed consent
5. Able to undergo brain MRI
6. Unilateral symptoms
7. 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
8. Use of one method of medically approved contraceptive

Exclusion Criteria:

1. History of any surgical intervention for treating PD (i.e. deep brain stimulation)
2. Extreme physical disability
3. History or current diagnosis of unstable psychiatric condition
4. Presence of dementia or any other condition that prevents the ability of the participant to provide fully informed consent
5. Other brain disease
6. Treatment with Memantine 30 days prior to baseline
7. Females who are pregnant or nursing
8. Presence of interacting medications with Memantine or co-morbid medical conditions that may be exacerbated by this agent
9. Moderately significant drug interactions with Dextromethorphan, Amantadine, Sodium Bicarbonate, and Acetazolamide
10. Previous Allergic reaction to Memantine
11. Any genetic form of PD

Primary outcomes:
measure: Change in Rey Auditory Verbal Learning Test (RAVLT) Scores (baseline to year-1)
timeFrame: Change from baseline RAVLT at year 1
measure: Change in Trail test performance time (baseline to year-1)
timeFrame: Change from baseline Trail test at year 1
measure: Change in Stroop Color Word Test performance (baseline to year-1)
timeFrame: Change from baseline Stroop Color Word Test at year 1
measure: Change Judgment of Line Orientation test performance score (baseline to year-1)
timeFrame: Change from baseline Judgment of Line Orientation test at year 1
Secondary outcomes:
measure: Change in the Intracellular volume (ICV), as measured by MRI NODDI sequence, in multiple brain regions, baseline to year-1.
timeFrame: Change from baseline to year-1 of ICV for each brain region mentioned above.
measure: Change in the mean kurtosis (MK), an index of tissue complexity, as measured by MRI diffusion kurtosis (DKI) sequence sequence, in multiple brain regions (mentioned in outcome #5), baseline to year-1.
timeFrame: Change from baseline to year-1 of MK for each brain region mentioned above.
measure: Change in cortical thickness (Cth), as measured by MRI T1 sequence, in multiple brain regions (mentioned in outcome #5), baseline to year-1.
timeFrame: Change from baseline to year-1 of Cth for each brain region mentioned above.
measure: 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.
timeFrame: Change from baseline to year-1 of FA for each brain region mentioned above.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References: