Jerome Yesavage
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Contact Information
VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
Condition(s):
Intervention(s):
- Drug: modafinil
Phase:
Phase 4Eligibility
Ages Eligible for Study:
Any Age to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can not participate as controls.Key Inclusion Criteria:
(1) A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
(2) 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.
Key Exclusion Criteria:
1) Participation in any other clinical drug trial
(2) Liver failure
(3) Believed by the investigator to be unwilling or unable to follow the protocol
(4) Active liver or coronary disease
Additional Study Details
Official Title:
Modafinil Treatment for Sleep/Wake Disturbances in Older AdultsAnticipated start date:
4/8/0008Lead Sponsor:
VAPAHCS - MIRECCInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- daytime alertness
Secondary Outcomes:
- cognitive function
- nighttime sleep
Total Number to be Enrolled:
8Total Number to be Enrolled at Stanford:
8More Information
Secondary ID(s):
- eprotocol 8564
Locations & Contacts
Stanford Locations & Contacts:
VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/10/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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