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Safety and Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients

NCT00706186 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2010-07-07

No results posted yet for this study

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.

Conditions

  • Mild Alzheimer's Disease

Interventions

DRUG

Sodium Oxybate

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.

Sponsors & Collaborators

  • St. Louis University

    collaborator OTHER

  • Clayton Sleep Insititute

    lead INDUSTRY

Principal Investigators

  • Eric Powell, PhD · Clayton Sleep Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00706186 on ClinicalTrials.gov