← Trials/Trial dossier/NCT00626210

TerminatedPhase 4Results posted

Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Lead sponsor

VA Palo Alto Health Care System

Asset

Modafinil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Nocturnal Sleep Length

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 ID8564

NCT IDNCT00626210

Timeline

Milestones

Study start2008-02 (month precision)

Study first posted2008-02-29estimated

Primary completion2011-04actual (month precision)

Study completion2012-10actual (month precision)

Results first posted2014-10-30estimated

Last update posted2019-10-28actual

Assets

Drug assets

Modafinil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (4)

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.

Coverage by outcome category

Behavior / neuropsychiatric

Caregiver / quality of life

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Nocturnal Sleep Length at 1 Month

Time frame:1 month

descriptive

Primary/registry result

Nocturnal Sleep Length at 1 Month

Time frame:1 month

descriptive

Posted result

Group	Value (median), hours	Reported bounds
Modafiniln=2 Participants	9.5	-9.5 - 9.5

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Improvement of Daytime Alertness and Quality of Life.

Time frame:~1 month

descriptive

Secondary/registry result

Improvement of Daytime Alertness and Quality of Life.

Time frame:~1 month

descriptive

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.