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

NCT00706186 | Terminated Phase 4 DMC

• 1 other identifier: ALD Xyrem
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 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

Keywords

Mild Alzheimer's; Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate and monitor the safety and tolerability of 6 to 9 g/day sodium oxybate in patients with mild Alzheimer's disease (AD) between the ages of 50 and 65 years.

  65 days

Interventions

Sodium Oxybate DRUG

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.

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clayton Sleep Insititute: lead
• St. Louis University: collaborator

Study Sites (1)

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

Related Publications (1)

• McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

  PMID: 33189083 DERIVED

MeSH Terms

Conditions

Disease

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Eric Powell, PhD

  Clayton Sleep Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 27, 2008
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

US (1)