Safety and Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients
Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Eligible patients will undergo this open label initial safety and feasibility study
investigating the use of 6 g/day sodium oxybate in mild AD. A total of 5 visits are included
with this trial and total subject participation duration of 7-8 weeks. The screening phase
will include an initial screening visit and a screening PSG night. After successful
screening, subjects will complete a baseline PSG night and undergo a third PSG night to
monitor initial safety and compliance with study drug at a dosage of 4.5 g/day of sodium
oxybate. Thus the subject will undergo three consecutive nights of PSG in the sleep center.
The patient will maintain a dosage of 4.5 g/day for a duration of 7 days leading to Treatment
Visit 1. After successful assessment at Treatment Visit 1, the dosage will be increased to 6
g/day for the duration of the trial. At Treatment Visit 2 (day 21), the dosage will be
increased to a dosage of 9 g/day, if tolerated by the patient. The remaining visit will occur
at 6 weeks after baseline, with Treatment Visit 3 consisting of two consecutive nights of
PSG. Participation will be complete after this visit. Phone follow-up will be made at one
week post completion visits to assess any wash-out symptoms. Please refer to Figure for flow
of the study design.