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

NCT03858270 | Unknown Phase 3 FDA Drug

• 1 other identifier: 09282018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  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.

  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.

  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.

  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.

  Change from baseline to year-1 of FA for each brain region mentioned above.

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Memantine DRUG

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.

Also known as: Namenda

Memantine

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with idiopathic PD for at least 2 or more years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Melody Hackett, BS

CONTACT

313-966-0473; mgilroy@med.wayne.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: February 28, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2023
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

US (1)