Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT03703856 |
Recruitment Status :
Recruiting
First Posted : October 12, 2018
Last Update Posted : April 12, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Drug: Memantine Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease |
Actual Study Start Date : | January 31, 2019 |
Estimated Primary Completion Date : | June 30, 2024 |
Estimated Study Completion Date : | June 30, 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Memantine |
Drug: Memantine
Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 88 carefully characterized patients with mild-to-moderate severity AD who are not currently taking AD medications. From this "challenge" test, a set of "early auditory information processing memantine sensitivity" measures will be derived for each patient. In Phase 2, all patients will begin an open-label trial of memantine monotherapy, titrated to 10 mg bid, with outcome measures collected after 8, 16 and 24 weeks of treatment. Medication adjustments are not restricted, and response heterogeneity is anticipated. |
Placebo Comparator: Placebo |
Drug: Placebo
Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 88 carefully characterized patients with mild-to-moderate severity AD who are not currently taking AD medications. From this "challenge" test, a set of "Early auditory information processing P memantine sensitivity" measures will be derived for each patient. In Phase 2, all patients will begin an open-label trial of memantine monotherapy, titrated to 10 mg bid, with outcome measures collected after 8, 16 and 24 weeks of treatment. Medication adjustments are not restricted, and response heterogeneity is anticipated. |
- Change from baseline measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 weeks [ Time Frame: 0, 8, 16, 24 weeks ]measures cognitive ability
- Change from baseline measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 weeks [ Time Frame: 0, 8, 16, 24 weeks ]measures behavioral symptoms
- Change from baseline measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 weeks [ Time Frame: 0, 8, 16, 24 weeks ]measures behavioral symptoms

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Ages Eligible for Study: | 50 Years to 83 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 < 40 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703856
Contact: Joyce Sprock | (619) 471-9455 | jsprock@ucsd.edu |
United States, California | |
Clinical Teaching Facility (CTF-B102) at UCSD Medical Center | Recruiting |
San Diego, California, United States, 92103 | |
Contact: Jo Talledo, B.A. 619-543-3093 atalledo@ucsd.edu | |
Principal Investigator: Neal R. Swerdlow, M.D., Ph.D. |
Principal Investigator: | Neal Swerdlow, M.D., Ph.D. | UCSD |
Responsible Party: | Neal R. Swerdlow, M.D., Ph.D., Principal Investigator, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03703856 |
Other Study ID Numbers: |
R01AG059640-01 ( U.S. NIH Grant/Contract ) |
First Posted: | October 12, 2018 Key Record Dates |
Last Update Posted: | April 12, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Alzheimer's Disease Alzheimer Disease Alzheimer AD Alzheimer's |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
Memantine Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |