Parkinson DiseasePhase 3NCT03858270
Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
A Phase 3 study testing Memantine in people with Parkinson Disease, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wayne State University
Detroit, Michigan, 48201
Melody Hackett, BS, 313-966-0473, mgilroy@med.wayne.edu
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Memantine, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Namenda
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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Memantine | Experimental | 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. Receives: Drug: Memantine |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rey Auditory Verbal Learning Test (RAVLT) Scores (baseline to year-1)
Investigate the effects of Memantine administration on the global cognitive status and executive function
Measured: Change from baseline RAVLT at year 1
Change in Trail test performance time (baseline to year-1)
Investigate the effects of Memantine administration on visual attention and task switching
Measured: Change from baseline Trail test at year 1
Change in Stroop Color Word Test performance (baseline to year-1)
Investigate the effects of Memantine administration on cognitive interference and processing speed
Measured: Change from baseline Stroop Color Word Test at year 1
Change Judgment of Line Orientation test performance score (baseline to year-1)
Investigate the effects of Memantine administration on visuospatial skills
Measured: Change from baseline Judgment of Line Orientation test at year 1
Secondary outcomes (4)
Change in the Intracellular volume (ICV), as measured by MRI NODDI sequence, in multiple brain regions, baseline to year-1.
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 )
Measured: Change from baseline to year-1 of ICV for each brain region mentioned above.
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.
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 )
Measured: Change from baseline to year-1 of MK for each brain region mentioned above.
Change in cortical thickness (Cth), as measured by MRI T1 sequence, in multiple brain regions (mentioned in outcome #5), baseline to year-1.
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 )
Measured: Change from baseline to year-1 of Cth for each brain region mentioned above.
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.
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 )
Measured: Change from baseline to year-1 of FA for each brain region mentioned above.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin George, MD, PhD, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858270
- Sponsor's protocol ID
- 09282018
- Status last verified
- Jun 2020
- First submitted
- 2 Oct 2018
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
- ClinicalTrials.gov ID
- NCT03858270
- Acronym / sponsor ID
- 09282018
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine | Experimental | Drug: MemantineMemantine 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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: NamendaMemantine 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 |
| PlaceboPlacebo 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 |
Primary outcome
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
4 secondary outcomes
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Memantine in people with Parkinson Disease, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melody Hackett, BS (313-966-0473, mgilroy@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rey Auditory Verbal Learning Test (RAVLT) Scores (baseline to year-1) (time frame: Change from baseline RAVLT at year 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.