Phase 4
N=53
Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03703856 ↗Enrolled (actual)
53
Serious AEs
3.8%
Results posted
Jan 2026
Primary outcome: Primary: Change From Baseline Measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 Weeks — 19.76; 19.81; 19.94; 20.79 scores on a scale — p=0.68
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Memantine (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 Weeks |
19.76; 19.81; 19.94; 20.79 | 0.68 |
| SECONDARY Change From Baseline Measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 Weeks |
4.27; 3.55; 3.05; 4.09 | >0.05 |
Summary
The effects of the medication, memantine, on brain functions and the symptoms of Alzheimer's Disease will be tested
Eligibility Criteria
Inclusion:
- Alzheimer's Disease Research Center-confirmed diagnosis of AD
- Mini-Mental State Examination (MMSE) score 10-22 OR a Montreal Cognitive Assessment (MOCA) score of 15-24
- Age 50-83 y
- Knowledgeable caregiver
- Ambulatory
- Medically stable;
- Audiometric testing (detection < or = to 45 db(A) at 1000 Hz)
- Informed consent
Exclusion:
- Active systemic illness (e.g. heart disease, liver failure, renal insufficiency, cancer, HIV, tuberculosis, Hepatitis C)
- Current psychiatric or neurologic illness other than AD
- History of vascular disease, myocardial infarction, cerebrovascular accidents, transient ischemic attack, seizure, head injury with loss of consciousness; substance dependence (including alcohol and Opioid)
- Past treatment with memantine; unable to tolerate acetylcholinesterase inhibitor
- Investigational drug treatment < 30 d of screening
- Current meds: amantadine, riluzole, other pro-cognitive medication, opioids
- Positive urine toxicology for non-prescribed psychoactive substance
- Actively enrolled in cognitive remediation therapy
Data sourced from ClinicalTrials.gov (NCT03703856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.