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Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT00626210
First received: February 20, 2008
Last updated: October 28, 2014
Last verified: October 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Nocturnal Sleep Length at 1 Month [ 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 ]

Enrollment: 2
Study Start Date: February 2008
Study Completion Date: October 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modafinil Drug: modafinil
100-400 mg daily for 4 weeks
Other Name: Provigil

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received: February 20, 2008
Results First Received: June 12, 2014
Last Updated: October 28, 2014
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:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on November 25, 2014