Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT03703856
Collaborator
(none)
88
1
2
65
1.4

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 31, 2019
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. 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

  1. 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

  1. 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

Ages Eligible for Study:
50 Years to 83 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
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
First Posted:
Oct 12, 2018
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 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
Keywords provided by Neal R. Swerdlow, M.D., Ph.D., Principal Investigator, University of California, San Diego
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022