Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

NCT00626210 | Terminated Phase 4 Results

• 1 other identifier: 8564
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Sleep Initiation and Maintenance Disorders; Alzheimer Disease

Keywords

Mild Cognitive Impairment (MCI); Sleep; Fatigue; Memory

Outcome Measures

Primary Outcomes (1)

• Nocturnal Sleep Length at 1 Month

  1 month

Secondary Outcomes (1)

• Improvement of Daytime Alertness and Quality of Life.

  ~1 month

Study Arms (1)

Modafinil

EXPERIMENTAL

Drug: modafinil

Interventions

modafinil DRUG

100-400 mg daily for 4 weeks

Also known as: Provigil

Modafinil

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (6)

• 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.

  PMID: 12716965 BACKGROUND

• 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.

  PMID: 11222668 BACKGROUND

• 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.

  PMID: 11069971 BACKGROUND

• 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.

  PMID: 15917462 BACKGROUND

• 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.

  PMID: 2436113 BACKGROUND

• 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.

  PMID: 33189083 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Alzheimer Disease; Cognitive Dysfunction; Fatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Cognition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Jamie Zeitzer
• Organization: VAPAHCS

jzeitzer@stanford.edu

6504935000

Study Officials

• Jamie M Zeitzer, PhD

  Stanford University/VAPAHCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2012
• Last Updated: October 28, 2019
• Results First Posted: October 30, 2014

Record last verified: 2019-10

Locations

US (1)