Lithium in Multiple System Atrophy

A Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Tolerability of Lithium in Multiple System Atrophy.

The purpose of this study is to determine safety and tolerability of the treatment with lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.

Patients will be progressively enrolled in the study and undergo a screening visit to test for inclusion/exclusion criteria. Patients will then be randomized to receive either Lithium carbonate or placebo. Patients will visit study center at 2, 4, 8, 12, 24, 36 and 48 weeks, for endpoint and laboratory assessments.

Inclusion Criteria:

• Clinical diagnosis of probable MSA (Gilman, et al. 2008)
• Age ≥18, <80

Exclusion Criteria:

• Heart failure
• Liver disease
• Kidney failure
• Thyroid disease
• Sick sinus syndrome and/or significant ECG alterations
• Hyposodemia
• Treatment with diuretics
• Treatment with haloperidol and/or other antipsychotics
• Treatment with NSAIDs or corticosteroids
• Treatment with ACE inhibitors
• Treatment with aminophyllines
• Treatment with mannitol
• Pregnancy and/or breastfeeding
• Acute diseases that might interfere with the trial