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Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine

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ClinicalTrials.gov Identifier: NCT03858270
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Navid Seraji-Bozorgzad, Wayne State University

Tracking Information
First Submitted Date  ICMJE October 2, 2018
First Posted Date  ICMJE February 28, 2019
Last Update Posted Date February 28, 2019
Estimated Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • 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 )
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
Official Title  ICMJE Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Memantine
  • 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2023
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03858270
Other Study ID Numbers  ICMJE 09282018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Navid Seraji-Bozorgzad, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wayne State University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP