Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
NCT ID: NCT00626210
Last Updated: 2019-10-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2008-02-29
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Modafinil
modafinil
100-400 mg daily for 4 weeks
Interventions
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modafinil
100-400 mg daily for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Liver failure
* Believed by the investigator to be unwilling or unable to follow the protocol
* Active liver or coronary disease
50 Years
ALL
No
Sponsors
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VA Palo Alto Health Care System
FED
Responsible Party
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Jamie M. Zeitzer, Ph.D.
Assistant Professor
Principal Investigators
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Jamie M Zeitzer, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University/VAPAHCS
Locations
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VA Palo Alto Health Care System
Palo Alto, California, United States
Countries
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References
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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. doi: 10.1523/JNEUROSCI.23-08-03555.2003.
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. doi: 10.1523/JNEUROSCI.21-05-01787.2001.
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. doi: 10.1523/JNEUROSCI.20-22-08620.2000.
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. doi: 10.1523/JNEUROSCI.0719-05.2005.
Saper CB, German DC. Hypothalamic pathology in Alzheimer's disease. Neurosci Lett. 1987 Mar 9;74(3):364-70. doi: 10.1016/0304-3940(87)90325-9.
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.
Other Identifiers
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8564
Identifier Type: -
Identifier Source: org_study_id
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