Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
Study Details
Study Description
Brief Summary
The effects of the medication, memantine, on brain functions and the symptoms of Alzheimer's Disease will be tested
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Memantine
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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.
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Placebo Comparator: Placebo
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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.
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Outcome Measures
Primary Outcome Measures
- Change from baseline measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 weeks [0, 8, 16, 24 weeks]
measures cognitive ability
Secondary Outcome Measures
- Change from baseline measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 weeks [0, 8, 16, 24 weeks]
measures behavioral symptoms
Other Outcome Measures
- Change from baseline measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 weeks [0, 8, 16, 24 weeks]
measures behavioral symptoms
Eligibility Criteria
Criteria
Inclusion:
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Alzheimer's Disease Research Center-confirmed diagnosis of AD
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Mini-Mental State Examination (MMSE) score 10-22 OR a Montreal Cognitive Assessment (MOCA) score of 15-24
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Age 50-83 y
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Knowledgeable caregiver
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Ambulatory
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Medically stable;
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Audiometric testing (detection < 40 db(A) at 1000 Hz)
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Informed consent
Exclusion:
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Active systemic illness (e.g. heart disease, liver failure, renal insufficiency, cancer, HIV, tuberculosis, Hepatitis C)
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Current psychiatric or neurologic illness other than AD
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History of vascular disease, myocardial infarction, cerebrovascular accidents, transient ischemic attack, seizure, head injury with loss of consciousness; substance dependence (including alcohol and Opioid)
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Past treatment with memantine; unable to tolerate acetylcholinesterase inhibitor
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Investigational drug treatment < 30 d of screening
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Current meds: amantadine, riluzole, other pro-cognitive medication, opioids
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Positive urine toxicology for non-prescribed psychoactive substance
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Actively enrolled in cognitive remediation therapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clinical Teaching Facility (CTF-B102) at UCSD Medical Center | San Diego | California | United States | 92103 |
Sponsors and Collaborators
- University of California, San Diego
Investigators
- Principal Investigator: Neal Swerdlow, M.D., Ph.D., UCSD
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01AG059640-01