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

This study has been terminated.
(Withdrawn by Investigator, protocol in revision)
Sponsor:
Collaborator:
St. Louis University
Information provided by:
Clayton Sleep Insititute
ClinicalTrials.gov Identifier:
NCT00706186
First received: June 24, 2008
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Mild Alzheimer's Disease
 Drug: Sodium Oxybate
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study Safety & Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clayton Sleep Insititute:

Primary Outcome Measures:
  • 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. [ Time Frame: 65 days ] [ Designated as safety issue: Yes ]

Enrollment: 4
Intervention Details:
    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.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Study inclusion:

  1. Ages 50 to 65 years
  2. Diagnosis of mild AD according to NINCDS-ACDRA criteria and a CDR scale score of 1.0 indicating mild dementia
  3. May be on approved AI's, but on a stable dose > 3 months prior to baseline and maintain dosage for duration of the study
  4. 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
  5. Complaint of sleep disturbance as measured by a score of >5 on the Pittsburgh Sleep Quality Index (PSQI)
  6. Fluent in the English language
  7. Able to comprehend and comply with all study related procedures

Exclusion Criteria:

  1. Previous history and diagnosis of a sleep disorder (such as sleep apnea, periodic limb movements, primary insomnia, or narcolepsy)
  2. 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.
  3. Current unstable major medical or psychiatric disorder (unrelated to dementia)
  4. A history of succinic semialdehyde dehydrogenase (SSADH) deficiency
  5. History of seizure disorder or major affective disorder
  6. History of substance abuse
  7. Poor gait and coordination
  8. 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.
  9. Typically consume > 600 mg caffeine in a 24 hour period and/or unwilling to refrain from caffeine consumption within 4 hours of bedtime
  10. Any patient, in the opinion of the investigator, that would not be appropriate for participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706186

Locations
United States, Missouri
Clayton Sleep Institute
St. Louis, Missouri, United States, 63143
Sponsors and Collaborators
Clayton Sleep Insititute
St. Louis University
Investigators
Study Director: Eric Powell, PhD Clayton Sleep Institute
  More Information

No publications provided

Responsible Party: Eric Powell, PhD, Clayton Sleep Institute
ClinicalTrials.gov Identifier: NCT00706186     History of Changes
Other Study ID Numbers: ALD Xyrem
Study First Received: June 24, 2008
Last Updated: July 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Clayton Sleep Insititute:
Mild Alzheimer's
Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Sodium Oxybate
 Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013