Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03858270 |
Recruitment Status :
Recruiting
First Posted : February 28, 2019
Last Update Posted : July 1, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: Memantine Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | April 1, 2022 |
Estimated Study Completion Date : | July 1, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Memantine
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.
|
Drug: Memantine
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.
Other Name: Namenda |
Placebo Comparator: Placebo
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.
|
Other: Placebo
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. |
- Change in Rey Auditory Verbal Learning Test (RAVLT) Scores (baseline to year-1) [ Time Frame: Change from baseline RAVLT at year 1 ]Investigate the effects of Memantine administration on the global cognitive status and executive function
- Change in Trail test performance time (baseline to year-1) [ Time Frame: Change from baseline Trail test at year 1 ]Investigate the effects of Memantine administration on visual attention and task switching
- Change in Stroop Color Word Test performance (baseline to year-1) [ Time Frame: Change from baseline Stroop Color Word Test at year 1 ]Investigate the effects of Memantine administration on cognitive interference and processing speed
- Change Judgment of Line Orientation test performance score (baseline to year-1) [ Time Frame: Change from baseline Judgment of Line Orientation test at year 1 ]Investigate the effects of Memantine administration on visuospatial skills
- Change in the Intracellular volume (ICV), as measured by MRI NODDI sequence, in multiple brain regions, baseline to year-1. [ Time Frame: Change from baseline to year-1 of ICV for each brain region mentioned above. ]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 calculated from baseline to year-1, and would constitute a regional outcome measure, but due to the number of regions, they have all been described under outcome#5, since they have the same unit of measurement. Group comparisons (i.e. placebo v. memantine for each region) will be corrected for multiple comparisons as appropriate (E.g Bonferroni )
- 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. [ Time Frame: Change from baseline to year-1 of MK for each brain region mentioned above. ]MK is calculated from the DKI MRI, using available software, for regions mentioned in outcome #5. The change in MK from each region will be calculated from baseline to year-1. Group comparisons (i.e. placebo v. memantine for each region) will be corrected for multiple comparisons as appropriate (E.g Bonferroni )
- Change in cortical thickness (Cth), as measured by MRI T1 sequence, in multiple brain regions (mentioned in outcome #5), baseline to year-1. [ Time Frame: Change from baseline to year-1 of Cth for each brain region mentioned above. ]Cth is calculated from T1 MRI, using available software, for regions mentioned in outcome #5. The change in Cth from each region will be calculated from baseline to year-1. Group comparisons (i.e. placebo v. memantine, for each region) will be corrected for multiple comparisons as appropriate (E.g Bonferroni )
- 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. [ Time Frame: Change from baseline to year-1 of FA for each brain region mentioned above. ]Utilizing FA to investigate white matter integrity in corpus callosum, inferior longitudinal fasciculus, and corona radiata. The change in FA from each region will be calculated from baseline to year-1. Group comparisons (i.e. placebo v. memantine, for each region) will be corrected for multiple comparisons as appropriate (E.g Bonferroni )

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 45 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
- History or current diagnosis of unstable psychiatric condition
- Presence of dementia or any other condition that prevents the ability of the participant to provide fully informed consent
- Other brain disease
- Treatment with Memantine 30 days prior to baseline
- Females who are pregnant or nursing
- Presence of interacting medications with Memantine or co-morbid medical conditions that may be exacerbated by this agent
- Moderately significant drug interactions with Dextromethorphan, Amantadine, Sodium Bicarbonate, and Acetazolamide
- Previous Allergic reaction to Memantine
- Any genetic form of PD

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858270
Contact: Melody Hackett, BS | 313-966-0473 | mgilroy@med.wayne.edu |
United States, Michigan | |
Wayne State University | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Melody Hackett, BS 313-966-0473 mgilroy@med.wayne.edu |
Responsible Party: | Edwin George, MD, PhD, Associate Professor of Neurology, Wayne State University |
ClinicalTrials.gov Identifier: | NCT03858270 |
Other Study ID Numbers: |
09282018 |
First Posted: | February 28, 2019 Key Record Dates |
Last Update Posted: | July 1, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Memantine |
Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |