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

NCT03703856 | Completed Phase 4 Results FDA Drug

• 1 other identifier: R01AG059640-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; Alzheimer Disease; Alzheimer; AD; Alzheimer's

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 Weeks

  The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a tool used to assess the severity of cognitive impairment in individuals with Alzheimer's disease. It includes 11 tasks that evaluate memory, language, and praxis. The total score can range from 0 to 70 with higher scores indicating more severe impairment.

  0, 8, 16, 24 weeks

Secondary Outcomes (1)

• Change From Baseline Measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 Weeks

  0, 8, 16, 24 weeks

Other Outcomes (1)

• Change From Baseline Measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 Weeks

  0, 8, 16, 24 weeks

Study Arms (1)

Memantine

OTHER

EAIP are assessed 210 (PPI) and 345 min (MMN, ASSR) after administration of placebo or memantine (MEM 20 mg po), in a randomized order double-blind design. In this arm subjects are administered MEM 20 mg. Pills look identical so both the subject and research staff are blind to condition.

Drug: Memantine

Interventions

Memantine DRUG

Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 32 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, 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.

Memantine

Eligibility Criteria

• Age: 50 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< or = to 45 db(A) at 1000 Hz)
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Clinical Teaching Facility (CTF-B102) at UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Neal R. Swerdlow, M.D., Ph.D.
• Organization: UCSD

nswerdlow@health.ucsd.edu

619-471-9455

Study Officials

• Neal Swerdlow, M.D., Ph.D.

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: January 31, 2019
• Primary Completion: January 8, 2025
• Study Completion: December 30, 2025
• Last Updated: April 16, 2026
• Results First Posted: January 7, 2026

Record last verified: 2025-07

Locations

US (1)