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

Status:

TERMINATED

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

Lead Sponsor:

Clayton Sleep Insititute

Collaborating Sponsors:

St. Louis University

Conditions:

Mild Alzheimer's Disease

Eligibility:

All Genders

50-65 years

Phase:

PHASE4

Brief 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 tot...

Detailed Description

Screening Visit (Day -14 to -7): To avoid confusion, all study visits will occur at the Clayton Sleep Institute. A spouse or caregiver is required to attend all visits. During the screening visit pot...

Eligibility Criteria

Inclusion

Study inclusion:
Ages 50 to 65 years
Diagnosis of mild AD according to NINCDS-ACDRA criteria and a CDR scale score of 1.0 indicating mild dementia
May be on approved AI's, but on a stable dose \> 3 months prior to baseline and maintain dosage for duration of the study
A reliable caregiver, who must reside with the patient, must be present and available for the duration of the study and must attend all study visits and spend the night in the sleep center for Night 3 for the baseline visit. Overnight stays for all other PSG procedures is optional for the caregiver
Complaint of sleep disturbance as measured by a score of \>5 on the Pittsburgh Sleep Quality Index (PSQI)
Fluent in the English language
Able to comprehend and comply with all study related procedures
Exclusion Criteria:
Previous history and diagnosis of a sleep disorder (such as sleep apnea, periodic limb movements, primary insomnia, or narcolepsy)
On screening polysomnogram (PSG) an apnea/hypopnea index (AHI) \> 15/hr using CMS criteria, oxygen desaturation \< 80%, or periodic limb movement arousal index \> 10/hr.
Current unstable major medical or psychiatric disorder (unrelated to dementia)
A history of succinic semialdehyde dehydrogenase (SSADH) deficiency
History of seizure disorder or major affective disorder
History of substance abuse
Poor gait and coordination
Currently taking CNS depressants, stimulants, or other medications in the opinion of the investigator that may affect sleep architecture (other than approved AI therapy). Consistent with study drug labeling, patients taking sedative/hypnotics and unable to washout of those medications at least 7 half-lives prior to completion of initial screening will be excluded.
Typically consume \> 600 mg caffeine in a 24 hour period and/or unwilling to refrain from caffeine consumption within 4 hours of bedtime
Any patient, in the opinion of the investigator, that would not be appropriate for participation in the study

Exclusion

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT00706186

Last Update

July 7 2010

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