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Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Primary Purpose

Insomnia, Sleep Initiation and Maintenance Disorders, Alzheimer Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
modafinil
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Mild Cognitive Impairment (MCI), Sleep, Fatigue, Memory

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Modafinil

Arm Description

Outcomes

Primary Outcome Measures

Nocturnal Sleep Length at 1 Month

Secondary Outcome Measures

Improvement of Daytime Alertness and Quality of Life.

Full Information

First Posted
February 20, 2008
Last Updated
October 24, 2019
Sponsor
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT00626210
Brief Title
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Official Title
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Initiation and Maintenance Disorders, Alzheimer Disease
Keywords
Mild Cognitive Impairment (MCI), Sleep, Fatigue, Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modafinil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
modafinil
Other Intervention Name(s)
Provigil
Intervention Description
100-400 mg daily for 4 weeks
Primary Outcome Measure Information:
Title
Nocturnal Sleep Length at 1 Month
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Improvement of Daytime Alertness and Quality of Life.
Time Frame
~1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie M Zeitzer, PhD
Organizational Affiliation
Stanford University/VAPAHCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12716965
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. doi: 10.1523/JNEUROSCI.23-08-03555.2003.
Results Reference
background
PubMed Identifier
11222668
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. doi: 10.1523/JNEUROSCI.21-05-01787.2001.
Results Reference
background
PubMed Identifier
11069971
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. doi: 10.1523/JNEUROSCI.20-22-08620.2000.
Results Reference
background
PubMed Identifier
15917462
Citation
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. doi: 10.1523/JNEUROSCI.0719-05.2005.
Results Reference
background
PubMed Identifier
2436113
Citation
Saper CB, German DC. Hypothalamic pathology in Alzheimer's disease. Neurosci Lett. 1987 Mar 9;74(3):364-70. doi: 10.1016/0304-3940(87)90325-9.
Results Reference
background
PubMed Identifier
33189083
Citation
McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
Results Reference
derived

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Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

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