Testing how well memantine works for Alzheimer's patients
Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
This study tests how well memantine works for people with Alzheimer's by comparing its effects on their brain functions and symptoms to those who receive a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 50 Years to 83 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT03703856 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of memantine on brain functions and symptoms in patients diagnosed with Alzheimer's Disease. It aims to identify biomarker predictors that may indicate sensitivity to memantine treatment. Participants will be randomly assigned to receive either memantine or a placebo, and their cognitive functions will be assessed throughout the study. The research is being conducted at the University of California, San Diego, utilizing a structured approach to evaluate treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-83 with a confirmed diagnosis of Alzheimer's Disease and specific cognitive assessment scores.
Not a fit: Patients with active systemic illnesses or other significant psychiatric or neurologic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for Alzheimer's patients based on their individual responses to memantine.
How similar studies have performed: Other studies have explored the effects of memantine in Alzheimer's patients, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: 1. Alzheimer's Disease Research Center-confirmed diagnosis of AD 2. Mini-Mental State Examination (MMSE) score 10-22 OR a Montreal Cognitive Assessment (MOCA) score of 15-24 3. Age 50-83 y 4. Knowledgeable caregiver 5. Ambulatory 6. Medically stable; 7. Audiometric testing (detection \< 40 db(A) at 1000 Hz) 8. Informed consent Exclusion: 1. Active systemic illness (e.g. heart disease, liver failure, renal insufficiency, cancer, HIV, tuberculosis, Hepatitis C) 2. Current psychiatric or neurologic illness other than AD 3. History of vascular disease, myocardial infarction, cerebrovascular accidents, transient ischemic attack, seizure, head injury with loss of consciousness; substance dependence (including alcohol and Opioid) 4. Past treatment with memantine; unable to tolerate acetylcholinesterase inhibitor 5. Investigational drug treatment \< 30 d of screening 6. Current meds: amantadine, riluzole, other pro-cognitive medication, opioids 7. Positive urine toxicology for non-prescribed psychoactive substance 8. Actively enrolled in cognitive remediation therapy
Where this trial is running
San Diego, California
- Clinical Teaching Facility (CTF-B102) at UCSD Medical Center — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Neal Swerdlow, M.D., Ph.D. — UCSD
- Study coordinator: Joyce Sprock
- Email: jsprock@ucsd.edu
- Phone: (619) 471-9455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.