Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

This study is currently recruiting participants.

Verified by VA Palo Alto Health Care System, January 2009

First Received: February 20, 2008 Last Updated: January 14, 2009 History of Changes

Sponsor:	VA Palo Alto Health Care System
Information provided by:	VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:	NCT00626210

Purpose

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.

Condition	Intervention	Phase
Insomnia Sleep Initiation and Maintenance Disorders Alzheimer Disease	Drug: modafinil	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:

Improvement of nighttime sleep quality and continuity. [ Time Frame: ~1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement of daytime alertness and quality of life. [ Time Frame: ~1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

100-400 mg daily for 4 weeks

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626210

Contacts

Contact: Ban Ku, BA	650-849-1971	bankusan@gmail.com
Contact: Jamie M Zeitzer, PhD	650-493-5000 ext 62410	jzeitzer@stanford.edu

Locations

United States, California
VA Palo Alto Health Care System	Recruiting
Palo Alto, California, United States, 94304
Contact: Ban Ku, BA 650-849-1971 bankusan@stanford.edu
Principal Investigator: Jamie M Zeitzer, PhD
Sub-Investigator: Jerome A Yesavage, MD
Sub-Investigator: Suhail Sheikh, MD
Sub-Investigator: Jared Tinklenberg, MD

Sponsors and Collaborators

VA Palo Alto Health Care System

Investigators

Principal Investigator:

Jamie M Zeitzer, PhD

Stanford University/VAPAHCS

More Information

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.

Responsible Party:	Stanford University/VA Palo Alto ( Dr. Jamie M. Zeitzer, Assistant Professor )
Study ID Numbers:	8564
Study First Received:	February 20, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00626210 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:

Mild Cognitive Impairment (MCI)
Sleep
Fatigue
Memory

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Dyssomnias
Sleep Disorders
Central Nervous System Stimulants
Brain Diseases
Neurodegenerative Diseases
Protective Agents

Neuroprotective Agents
Pharmacologic Actions
Modafinil
Sleep Disorders, Intrinsic
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009