A Double Blind Comparison of Galantamine Hydrobromide ER and Placebo in Parkinson’s Disease

Abstract

Objective: To study the efficacy and safety of galantamine hydrobromide ER for the enhancement of cognition in non-demented Parkinson’s patients (PD).

Methods: Sixty-nine non-demented PD participants were randomized in a double blind, placebo controlled study of galantamine or placebo. Galantamine was administered over 16 weeks (8mg/day for 4 weeks, a therapeutic dose of 16mg/day for 6 weeks, and maximum dose of 24mg/day for 6 weeks). Outcome measures were neuropsychological (attention, verbal fluency, executive, memory, visuospatial), behavioral (Frontal Systems Behavior Scale, quality of life, Neuropsychiatric Inventory-Questionnaire, PDQ-39), and motor (UPDRS).

Results: Twenty-six individuals on active medication and twenty-eight individuals on placebo were included in the outcome analyses. No significant differences were found between the active and placebo groups on cognitive, behavioral or motor outcome measures. Most common adverse events were gastrointestinal and self reported worsening of PD symptoms.

Conclusions: Contrary to our hypotheses, galantamine treatment did not improve attention/executive, memory or visuospatial performance in non demented PD patients. Further, there was a high, statistically significant drop out rate in the treatment group due to gastrointestinal side effects and self reported worsening of PD symptoms. Treatment with galantamine did not enhance self-perception of mental sharpness or quality of life. No negative behavioral change such as hallucinations or apathy was found with treatment.