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CompletedPhase 4Results posted

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

An Open Label, Single-Center Pilot Study of Armodafinil in Patients With Dementia With Lewy Bodies

Lead sponsor

Mayo Clinic

Asset

Armodafinil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•MMSE 10-26•Study partner/caregiver required

Primary endpoint

•Mean Initial Sleep Latency

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID09-003438

NCT IDNCT01023672

NihP50AG016574

NihR01AG015866

Timeline

Milestones

Study start2009-11 (month precision)

Study first posted2009-12-02estimated

Primary completion2012-03actual (month precision)

Study completion2012-03actual (month precision)

Last update posted2013-09-05estimated

Results first posted2013-09-05estimated

Assets

Drug assets

Armodafinil

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

•Medication regimen has not been stable over preceding four weeks

•Concurrent use of lamotrigine or oxcarbazepine

•Presence of over-the-counter and prescription psychotropic medications at doses viewed by the clinician to be significantly impacting the patient's alertness during wakefulness, such as:

-Clonazepam > 1 mg/night

-Seroquel > 100 mg/night

-Zyprexa > 10 mg/night

•Presence of another clinically-significant primary sleep disorder (eg, UARS, OSA, CSA) that is not being treated

•Clinically significant abnormalities on screening ECG or laboratory tests

•Patient or caregiver unwilling or unable to participate in all study-related procedures

•Caregiver is not with patient at least 4 hours/day for at least 5 days/week

•Patient or caregiver unwilling or unable to provide informed consent

•CT or MRI evidence of a clinically significant structural lesion that could account for the participants dementia

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

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

Time frame:baseline, 12 weeks

descriptive

Primary/registry result

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

Time frame:baseline, 12 weeks

descriptive

Posted result

Group	Value (median), minutes	Reported bounds
ArmodifinilBaselinen=17 Participants	7.0	-4.25 - 19.07
12 Weeksn=17 Participants	19.0	-7.19 - 32.76

p0.003Wilcoxon (Mann-Whitney)

The analysis was done per protocol (n=17)

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.