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

NCT ID: NCT03858270

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Memantine

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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 Type: DRUG

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 Type: OTHER

Other Intervention Names

Namenda

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Edwin George, MD, PhD

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wayne State University

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melody Hackett, BS

Role: CONTACT

mgilroy@med.wayne.edu

313-966-0473

Facility Contacts

Melody Hackett, BS

Role: primary

mgilroy@med.wayne.edu

313-966-0473

Other Identifiers

09282018

Identifier Type: -

Identifier Source: org_study_id