Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Information source: VA Palo Alto Health Care System
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia; Sleep Initiation and Maintenance Disorders; Alzheimer Disease
Intervention: modafinil (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: VA Palo Alto Health Care System Official(s) and/or principal investigator(s):
Jamie M Zeitzer, PhD, Principal Investigator, Affiliation: Stanford University/VAPAHCS
Overall contact:
Ban Ku, BA, Phone: 650-849-1971, Email: bankusan@gmail.com
Summary
Modafinil, trade named Provigil, is a medication approved by the Food and Drug
Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome,
and shift work sleep disorder. Each of these problems is characterized by difficulty
sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day
to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads
to napping during the day prevents a patient from being tired or sleepy enough to get good
sleep at night. This study is designed to determine if the medication can "reset"
participants' sleep/wake rhythm to a more normal rhythm.
Clinical Details
Official title: Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Improvement of nighttime sleep quality and continuity.
Secondary outcome: Improvement of daytime alertness and quality of life.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
- Subjective complaint of sleep disruption, unsatisfactory sleep, early morning
awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made
by either the potential participant or by the caregiver.
Exclusion Criteria:
- Participation in any other clinical drug trial
- Liver failure
- Believed by the investigator to be unwilling or unable to follow the protocol
- Active liver or coronary disease
Locations and Contacts
Ban Ku, BA, Phone: 650-849-1971, Email: bankusan@gmail.com
VA Palo Alto Health Care System, Palo Alto, California 94304, United States; Recruiting
Ban Ku, BA, Phone: 650-849-1971, Email: bankusan@stanford.edu
Jamie M Zeitzer, PhD, Principal Investigator
Jerome A Yesavage, MD, Sub-Investigator
Suhail Sheikh, MD, Sub-Investigator
Jared Tinklenberg, MD, Sub-Investigator
Additional Information
Related publications: Zeitzer JM, Buckmaster CL, Parker KJ, Hauck CM, Lyons DM, Mignot E. Circadian and homeostatic regulation of hypocretin in a primate model: implications for the consolidation of wakefulness. J Neurosci. 2003 Apr 15;23(8):3555-60. Wisor JP, Nishino S, Sora I, Uhl GH, Mignot E, Edgar DM. Dopaminergic role in stimulant-induced wakefulness. J Neurosci. 2001 Mar 1;21(5):1787-94. Scammell TE, Estabrooke IV, McCarthy MT, Chemelli RM, Yanagisawa M, Miller MS, Saper CB. Hypothalamic arousal regions are activated during modafinil-induced wakefulness. J Neurosci. 2000 Nov 15;20(22):8620-8. Lambe EK, Olausson P, Horst NK, Taylor JR, Aghajanian GK. Hypocretin and nicotine excite the same thalamocortical synapses in prefrontal cortex: correlation with improved attention in rat. J Neurosci. 2005 May 25;25(21):5225-9. Saper CB, German DC. Hypothalamic pathology in Alzheimer's disease. Neurosci Lett. 1987 Mar 9;74(3):364-70.
Starting date: February 2008
Ending date: September 2010
Last updated: January 14, 2009
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