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NMDA receptor antagonist

Memantine for Amyotrophic Lateral Sclerosis (TAME Trial)

Phase 2
Waitlist Available
Led By Richard D Barohn, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks of treatment
Awards & highlights

Summary

This trial will study whether memantine can help slow the progression of ALS and improve neuropsychiatric changes. Serum biomarkers will be studied as both a diagnostic and a prognostic marker in patients with ALS.

Eligible Conditions
  • Amyotrophic Lateral Sclerosis
  • Frontotemporal Dementia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Primary Comparison for Efficacy Will be Based on a Linear Mixed Effects (LME) Model Fit to the ALSFRS-R Data for the Patients Followed Over 36 Weeks.
Secondary study objectives
Measuring the levels of Tau, pNFH and the pNFH/C3 ratio in blood
Other study objectives
Measuring the Levels of Tau, Phosphorylated Neurofilament Heavy Chain (pNFH) and the pNFH/C3 Ratio in Blood
Slowing of Behavioral Decline in Those With FTD Characteristics Based on the NPI-Q and the ALS-Cognitive Behavioral Screen (CBS)™

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MemantineActive Control1 Intervention
Up to 20 mg memantine taken by mouth twice a day for 36 weeks
Group II: PlaceboPlacebo Group1 Intervention
Up to 2 placebo tablets taken by mouth twice a day for 36 weeks

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
488 Previous Clinical Trials
172,366 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
29 Patients Enrolled for Amyotrophic Lateral Sclerosis
University of Missouri-ColumbiaOTHER
376 Previous Clinical Trials
628,572 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
112 Patients Enrolled for Amyotrophic Lateral Sclerosis
Richard D Barohn, MDPrincipal InvestigatorUniversity of Kansas Medical Center
~13 spots leftby Sep 2025
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