Memantine Therapy in Amyotrophic Lateral Sclerosis

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phoenix Neurological Associates, LTD
• Collaborator: Forest Laboratories
• Treatments: Memantine

Criteria

Inclusion Criteria

1. Age 18-85

2. Male or Female

3. Clinically definite ALS by El Escorial criteria

4. Elevated levels of Tau in CSF

Exclusion Criteria:

1. Patients with FVC below 1.5 L or who require respiratory assistance

2. History of liver disease

3. Severe renal failure

4. History of intolerance to Riluzole or Memantine

5. Any other co morbid condition which would make completion of trial unlikely

6. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control.

7. Taking any trial medications. Non-trial medications are not cause for exclusion.

8. Unwillingness to provide consent