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Armodafinil

WithdrawnPhase NA

Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies

Lead sponsor

NYU Langone Health

Asset

Armodafinil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MMSE ≤24

Primary endpoint

•EGI netstation software and a custom made software that runs on the Matlab

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 ID09-0189

NCT IDNCT01256905

Timeline

Milestones

Study first posted2010-12-09estimated

Study start2011-01-01actual

Primary completion2011-08-08actual

Study completion2011-08-08actual

Last update posted2021-08-23actual

Assets

Drug assets

Armodafinil

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Established criteria for diagnosis of PDD (Parkinsons Disease) {Emre M et al. Mov Disord 2007;22:1689-707} and DLB (Lewy Bodies Disease) {McKeith et al. Neurology 2005;65:1863-72}

•Mini Mental State Examination (MMSE) score between <24; and/or Dementia Rating

•Scale-2 (DRS-2) score <134;

•Clinical Assessment of Fluctuation (CAF)>4;

•Stable anti-parkinsonian medication in the 4 weeks preceding the study

Exclusion criteria

•Use of cognitive enhancers (Donepezil, Rivastigmine, Galantamine, Modafinil, Memantine) in the last 4 weeks:

Concomitant use of any medication contraindicated with modafinil/armodafinil; History of alcohol and substances abuse. Use of medications known to alter the normal EEG activity in humans during the study period (i.e. clonazepam) History of psychiatric disorders, other than depression and psychiatric complication of PDD and DLB

Endpoints (1)

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.

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)

Time frame:2 hours

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.