Memantine Therapy in Amyotrophic Lateral Sclerosis

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

Tau, a protein in the cerebrospinal fluid CSF is believed to be elevated in amyotrophic lateral sclerosis (ALS) patients. The investigators believe that Tau is truly a marker of increased neuronal death from any disease process. It is been shown that Memantine can inhibit and reverse the abnormal hyperphosphorylation of Tau and therefore the investigators are looking at the efficacy of Memantine at 10 mg twice a day (BID) to see if disease progression correlates with possible changes in Tau in ALS patients based on ALS Functional Rating Scale (ALSFRS) scores.

Key facts

Study ID

NCT01020331

Run by

Phoenix Neurological Associates, LTD

People needed

20

Starts

2005-06-01

Expected to finish

2009-10-01

Last updated by the study team

2009-11-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-85
• Male or Female
• Clinically definite ALS by El Escorial criteria
• Elevated levels of Tau in CSF

You may not qualify if…

• Patients with FVC below 1.5 L or who require respiratory assistance
• History of liver disease
• Severe renal failure
• History of intolerance to Riluzole or Memantine
• Any other co morbid condition which would make completion of trial unlikely
• If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control.
• Taking any trial medications. Non-trial medications are not cause for exclusion.
• Unwillingness to provide consent

Where it is running

• Phoenix Neurological Associates, LTD — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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