Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

• Sponsor: VA Palo Alto Health Care System (U.S. Fed)
• Overall Status: Terminated
• CT.gov ID: NCT00626210
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 56
• Patients Per Site Per Month: 0

Study Details

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.

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

Study Design

• Study Type: Interventional
• 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: Feb 1, 2008
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Modafinil	Drug: modafinil; 100-400 mg daily for 4 weeks; Other Names: Provigil

Outcome Measures

Primary Outcome Measures

1. Nocturnal Sleep Length at 1 Month [1 month]

Secondary Outcome Measures

1. Improvement of Daytime Alertness and Quality of Life. [~1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Jamie M. Zeitzer, Ph.D., Assistant Professor, VA Palo Alto Health Care System
• ClinicalTrials.gov Identifier: NCT00626210
• Other Study ID Numbers: 8564
• First Posted: Feb 29, 2008
• Last Update Posted: Oct 28, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Jamie M. Zeitzer, Ph.D., Assistant Professor, VA Palo Alto Health Care System: Mild Cognitive Impairment (MCI); Sleep; Fatigue; Memory
• Additional relevant MeSH terms: Alzheimer Disease; Sleep Initiation and Maintenance Disorders; Modafinil

Study Results

Participant Flow

Arm/Group Title	Modafinil
Arm/Group Description	daily 100 mg of modafinil within 1 hr of awakening for one week followed by daily 200 mg of modafinil within 1 hr of awakening for one week
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Modafinil
Arm/Group Description	Open label study in which all participants get modafinil
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	2 100%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Nocturnal Sleep Length at 1 Month
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Modafinil
Arm/Group Description
Measure Participants	2
Median (Full Range) [hours]	9.5

2. Secondary Outcome

Title	Improvement of Daytime Alertness and Quality of Life.
Time Frame	~1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Modafinil
Arm/Group Description
All Cause Mortality
	Modafinil
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Modafinil
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Modafinil
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.