GM-1 treatment of Alzheimer's disease. A pilot study of safety and efficacy
T. Ala, S. Romero, F. Knight, K. Feldt and W. H. Frey 2nd
Alzheimer's Treatment and Research Center, Ramsey Clinic/St Paul-Ramsey Medical Center, MN.
A double-blind, placebo-controlled pilot study was conducted to evaluate
the safety and efficacy of treatment of patients with Alzheimer's disease
using monosialoganglioside GM-1, a neurotrophic factor. Of 46 patients
enrolled, 42 completed all study requirements. Nineteen patients received
100 mg of GM-1 by daily intramuscular injection for 12 weeks. Twenty-three
patients received placebo. Case evaluations were done at baseline, week 12,
and week 24 and included both cognitive and psychosocial scales. Study
results suggested that the treatment was safe, yet offered no overall
symptomatic benefit to patients with mild-to-moderate Alzheimer's disease.
Whether or not GM-1 therapy may offer protective benefit by slowing or
arresting the progression of the disease remains unclear, since the results
of the cognitive evaluations suggested that neither the GM-1 group nor the
placebo group declined significantly during the 24-week study.
