Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Alzheimer Disease Clinical Trial

Official title:

Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00626210
• Other study ID #: 8564
• Status: Terminated
• Phase: Phase 4
• Start date: February 2008
• Est. completion date: October 2012

Study information

• Verified date: October 2019
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• modafinil
100-400 mg daily for 4 weeks

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Saper CB, German DC. Hypothalamic pathology in Alzheimer's disease. Neurosci Lett. 1987 Mar 9;74(3):364-70. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal Sleep Length at 1 Month		1 month
Secondary	Improvement of Daytime Alertness and Quality of Life.		~1 month