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

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Alzheimer Disease, Alzheimer, AD, Alzheimer's

Eligibility Criteria

50 Years - 83 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Teaching Facility (CTF-B102) at UCSD Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Memantine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 weeks
measures cognitive ability

Secondary Outcome Measures

Change from baseline measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 weeks
measures behavioral symptoms

Full Information

First Posted
October 9, 2018
Last Updated
May 1, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03703856
Brief Title
Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
Official Title
Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

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

5. Study Description

Brief Summary
The effects of the medication, memantine, on brain functions and the symptoms of Alzheimer's Disease will be tested

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's Disease, Alzheimer Disease, Alzheimer, AD, Alzheimer's

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Memantine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 weeks
Description
measures cognitive ability
Time Frame
0, 8, 16, 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 weeks
Description
measures behavioral symptoms
Time Frame
0, 8, 16, 24 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 weeks
Description
measures behavioral symptoms
Time Frame
0, 8, 16, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
83 Years
Accepts Healthy Volunteers
No
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 < 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joyce Sprock
Phone
(619) 471-9455
Email
jsprock@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Swerdlow, M.D., Ph.D.
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Teaching Facility (CTF-B102) at UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Talledo, B.A.
Phone
619-543-3093
Email
atalledo@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Neal R. Swerdlow, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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