Clinical trial NCT00626210: Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Official title: Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Insomnia
Sleep Initiation and Maintenance Disorders
Alzheimer Disease
Keywords: Mild Cognitive Impairment (MCI)
Sleep
Fatigue
Memory
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2008-02-29
Enrollment: 2
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Nocturnal Sleep Length at 1 Month
timeFrame: 1 month
Secondary outcomes:
measure: Improvement of Daytime Alertness and Quality of Life.
timeFrame: ~1 month
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: Stanford University/VAPAHCS
name: Jamie M Zeitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.