The phase I trial conducted in early 2005 was designed to evaluate AL-108’s safety, tolerability and pharmacokinetics in healthy subjects. The study was double-blind by design and participants received a single ascending intranasal dose of the drug or a placebo.
A total of 30 subjects were randomized to one of five dose groups. A single subject in each group received placebo. The dose groups were one, three, 10, 12.5 and 15mg of AL-108 or placebo administered intranasally. Approximately two-thirds of the subjects were female and the mean age was 31 years with the total age range being between 19 to 44 years. The study was conducted by MDS Pharma in Phoenix Arizona.
Gordon McCauley, president and CEO of Allon said: “AL-108 appears to be safe, well tolerated and no serious adverse events were reported. None of the chemistry, hematology or urinalysis laboratory results was considered to be clinically significant by the principal investigator. Furthermore, there were no clinically significant changes in electrocardiograms or vital signs measured in any subject during the observation period.”
Scientists agree that the brains of Alzheimer’s patients are characterized by plaque accumulation outside brain cells, or neurons, and by neurofibrillary tangles inside the neurons. No drug on the market today has any impact on these plaques and tangles. Drugs on the market today treat only the symptoms of Alzheimer’s by slowing memory loss, modifying emotional volatility or treating other behavioral symptoms.
Preclinical studies have shown that AL-108 removes plaques and promotes the repair of neurofibrillary tangles. AL-108 also protects healthy neurons from the formation of plaques and tangles.
A second phase I clinical trial is scheduled to begin later in 2005 with results anticipated early in 2006. This study will evaluate the drug’s safety in elderly healthy individuals.