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 randomised in a double-blind, placebo-controlled study of galantamine or placebo. Galantamine was administered over 16 weeks (8 mg/day for 4 weeks, a therapeutic dose of 16 mg/day for 6 weeks and a maximum dose of 24 mg/day for 6 weeks). Outcome measures were neuropsychological (attention, verbal fluency, executive, memory, visuospatial), behavioural (Frontal Systems Behavior Scale, Neuropsychiatric Inventory-Questionnaire, PDQ-39) and motor (Unified Parkinson’s Disease Rating Scale motor scale).
Results: 26 individuals on active medication and 28 individuals on placebo were included in the outcome analyses. No significant differences were found between the active and placebo groups on cognitive, behavioural 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 behavioural change such as hallucinations or apathy was found with treatment.
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Funding: MMA received funds by Ortho-McNeil Pharmaceutical, Inc for coordination of this clinical trial. JHF received funds for a staff member (nurse for medical monitoring and drug dispensing) from Ortho-McNeil Pharmaceutical, Inc for this clinical trial.
Competing interests: This study was supported as an investigator-initiated clinical trial by Ortho-McNeil Pharmaceutical, Inc.
Ethics approval: Ethics approval was provided by the Memorial Hospital of RI Institutional Review Board.
Patient consent: Obtained.