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Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

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ClinicalTrials.gov Identifier: NCT00626210
Recruitment Status : Terminated
First Posted : February 29, 2008
Results First Posted : October 30, 2014
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System

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.

Condition or disease Intervention/treatment Phase
Insomnia Sleep Initiation and Maintenance Disorders Alzheimer Disease Drug: modafinil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Study Start Date : February 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : October 2012


Arm Intervention/treatment
Experimental: Modafinil Drug: modafinil
100-400 mg daily for 4 weeks
Other Name: Provigil



Primary Outcome Measures :
  1. Nocturnal Sleep Length at 1 Month [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Improvement of Daytime Alertness and Quality of Life. [ Time Frame: ~1 month ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626210


Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
Investigators
Principal Investigator: Jamie M Zeitzer, PhD Stanford University/VAPAHCS

Publications:
Responsible Party: Jamie M. Zeitzer, Ph.D., Assistant Professor, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT00626210     History of Changes
Other Study ID Numbers: 8564
First Posted: February 29, 2008    Key Record Dates
Results First Posted: October 30, 2014
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System:
Mild Cognitive Impairment (MCI)
Sleep
Fatigue
Memory

Additional relevant MeSH terms:
Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs