"Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies"

NCT01023672 | Completed Phase 4 Results

• 3 other identifiers: 09-003438R01AG015866P50AG016574
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is to examine the effects of the study medication Armodafinil in patients with dementia with Lewy bodies (DLB). DLB is associated with memory and other thinking problems, excessive daytime sleepiness, hallucinations, delusions, apathy, and reduced quality of life. One type of medication that could potentially improve daytime sleepiness, memory and thinking skills, hallucinations, delusions, apathy, and quality of life is known as a wake-promoting medication. Armodafinil is a wake-promoting medication that has been developed for treatment of patients with narcolepsy, sleep apnea, and other disorders which cause excessive daytime sleepiness. The drug used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug/device in this research study. In this study, patients with DLB will receive daily oral Armodafinil tablets, and their response to treatment will be assessed over 12 weeks. This study does not involve any placebo medication, so all patients will receive Armodafinil treatment.

Conditions

Dementia With Lewy Bodies

Keywords

Dementia with Lewy Bodies; hypersomnolence; cognition; neuropsychiatric morbidity; quality of life

Outcome Measures

Primary Outcomes (1)

• Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)

  The MWT measures the subject's ability to stay awake while sitting quietly in a chair. The test has 4 parts, each lasting 40 minutes if the subject is able to remain awake that long each time, and the parts are spaced apart in 2 hour intervals through the day. The subject is placed in a dim room, with the only source of light slightly behind the subject's head and out of his/her field of vision, and back and neck supported. During this time the subject is monitored with the same measures that are used in a standard overnight sleep study called a polysomnogram. The sleep latency, or time it takes the subject to fall asleep, will be recorded. In healthy people, the time it takes to fall asleep may be approximately 30 minutes on the test. More than 97% of people will take eight minutes or longer to fall asleep. Therefore, sleep latency that is less than eight minutes is considered to be abnormal.

  baseline, 12 weeks

Study Arms (1)

Armodifinil

OTHER

150-250 mg armodafinil by mouth daily

Drug: Armodafinil

Interventions

Armodafinil DRUG

150-250 mg armodafinil by mouth daily

Also known as: Nuvigil

Armodifinil

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinically possible or probable DLB using established criteria
• Age 50-90 inclusive
• Epworth Sleepiness Scale score of 8 or greater
• MMSE score between 10 and 26 inclusive
• No active medical disorder that could preclude participation in a drug treatment trial over a 12 week protocol
• Stable medication regimen over previous four weeks
• Absence of psychotropic medications at doses viewed by the clinician to be significantly impacting the patient's alertness during wakefulness
• Absence of clinically significant primary sleep-related breathing disorder causing sleepiness as demonstrated by polysomnography (PSG) \[ie, no significant upper airway resistance syndrome (UARS), obstructive sleep apnea (OSA), nor central sleep apnea (CSA) as reflected by a combined respiratory disturbance index (RDI) \<15\] OR adequate documentation of efficacy of treatment for UARS, OSA, and CSA
• Caregiver that is with the patient at least 4 hours/day for at least 5 days per week
• Patient and caregiver willing and able to participate in all study-related procedures
• Patient is capable of giving informed consent, or if appropriate, has caregiver capable of giving consent on the subject's behalf.

You may not qualify if:

• Does not fulfill criteria for clinically possible or probable DLB
• Age \<50 or \>90
• Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative
• Epworth Sleepiness Scale score less than 8
• MMSE score \<10 or \>26
• Active medical disorder that could preclude participation in a drug treatment trial over a 52 week protocol, such as:
• Hypertension with BP readings exceeding 150 mm Hg systolic and 90 mm Hg diastolic
• Hypersensitivity to modafinil, armodafinil, or any other conventional stimulants
• Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease
• History of left ventricular hypertrophy or mitral valve prolapse
• History of chronic or paroxysmal atrial fibrillation, chronic or paroxysmal atrial flutter, ventricular fibrillation, or ventricular tachycardia
• History of cancer over preceding 1 year (excluding squamous or basal cell carcinoma of the skin)
• History of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS)
• Pulmonary disease requiring oral or inhalatory medications
• Any other medical disorder considered by the study physicians as inappropriate for any wake-promoting medication

Sponsors & Collaborators

• Mayo Clinic: lead
• Cephalon: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lewy Body Disease; Disorders of Excessive Somnolence

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Bradley F. Boeve
• Organization: Mayo Clinic

bboeve@mayo.edu

507-266-4106

Study Officials

• Bradley F Boeve, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 5, 2013
• Results First Posted: September 5, 2013

Record last verified: 2013-06

Locations

US (1)