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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 : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Neal R. Swerdlow, M.D., Ph.D., University of California, San Diego

Study Description
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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
Alzheimer Disease Drug: Memantine Drug: Placebo Phase 4

Study Design
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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 : August 2023
Estimated Study Completion Date : August 2023

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 50-80 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jo Talledo Benrubi 6195433093 atalledo@ucsd.edu

Locations
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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.         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Neal Swerdlow, M.D., Ph.D. UCSD
More Information
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Responsible Party: Neal R. Swerdlow, M.D., Ph.D., Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03703856     History of Changes
Other Study ID Numbers: R01AG059640-01 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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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
Keywords provided by Neal R. Swerdlow, M.D., Ph.D., University of California, San Diego:
Alzheimer's Disease
Alzheimer Disease
Alzheimer
AD
Alzheimer's
Additional relevant MeSH terms:
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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