← Trials/Trial dossier/NCT01172145

CompletedPhase 3Results posted

Treatment of Apathy in Alzheimer's Disease With Modafinil

Lead sponsor

Brown University

Asset

Modafinil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•AD symptomatic therapy: stable

Primary endpoint

•Apathy

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 ID1F32MH075583-01https://reporter.nih.gov/quickSearch/1F32MH075583-01

Nih1F32MH075583-01

NCT IDNCT01172145

Timeline

Milestones

Study start2005-07 (month precision)

Study completion2007-09actual (month precision)

Study first posted2010-07-29estimated

Last update posted2011-03-04estimated

Results first posted2011-03-04estimated

Assets

Drug assets

Modafinil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years

Maximum age95 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•diagnosis of mild to moderate stage Probable Alzheimer's disease

•on a stable dose of a cholinesterase inhibitor medication for at least 30 days

•clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale

Exclusion criteria

•diagnosis of Major Depression

•focal brain lesion on neuroimaging

•history of significant substance abuse

•history of significant head trauma with loss if consciousness >10 minutes

Endpoints (16)

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

Function / daily living

Behavior / neuropsychiatric

Function / daily living

8 endpoints

Secondary/protocol endpoint

Lawton Brody Activities of Daily Living Questionnaire

Time frame:at baseline

ratio, descriptive

Secondary/protocol endpoint

The Direct Assessment of Functional Status Scale

Time frame:at baseline

categorical status, descriptive

Secondary/protocol endpoint

Lawton Brody Activities of Daily Living Questionnaire

Time frame:after 8 weeks of treatment

ratio, descriptive

Secondary/protocol endpoint

The Direct Assessment of Functional Status Scale

Time frame:after 8 weeks of treatment

categorical status, descriptive

Secondary/registry result

Lawton Brody Activities of Daily Living Questionnaire

Time frame:at baseline

ratio, descriptive

Posted result

Group	Value (mean), raw score	Standard deviation
Cholinesterase Inhibitor Onlyn=11 Participants	19.00	5.25
Cholinesterase Plus Modafiniln=11 Participants	16.18	4.81

Secondary/registry result

The Direct Assessment of Functional Status Scale

Time frame:at baseline

categorical status, descriptive

Posted result

Group	Value (mean), raw score	Standard deviation
Cholinesterase Inhibitor Onlyn=11 Participants	89.09	7.84
Cholinesterase Plus Modafiniln=11 Participants	84.55	16.11

Secondary/registry result

Lawton Brody Activities of Daily Living Questionnaire

Time frame:after 8 weeks of treatment

ratio, descriptive

Posted result

Group	Value (mean), raw score	Standard deviation
Cholinesterase Inhibitor Onlyn=11 Participants	19.00	5.54
Cholinesterase Plus Modafiniln=11 Participants	15.64	5.43

Secondary/registry result

The Direct Assessment of Functional Status Scale

Time frame:after 8 weeks of treatment

categorical status, descriptive

Posted result

Group	Value (mean), raw score	Standard deviation
Cholinesterase Inhibitor Onlyn=11 Participants	88.36	8.35
Cholinesterase Plus Modafiniln=11 Participants	85.27	14.16

Behavior / neuropsychiatric

8 endpoints

Primary/protocol endpoint

Apathy

Time frame:at baseline

descriptive

Primary/protocol endpoint

Apathy

Time frame:after 8 weeks of treatment

descriptive

Primary/registry result

Apathy

Time frame:at baseline

descriptive

Posted result

Group	Value (mean), T-score	Standard deviation
Cholinesterase Inhibitor Onlyn=11 Participants	88.91	11.95
Cholinesterase Plus Modafiniln=11 Participants	95.64	10.79

Mean Difference (Final Values)-1.38595% CI-16.86 - 3.40p0.181t-test, 2 sided

Primary/registry result

Apathy

Time frame:after 8 weeks of treatment

descriptive

Posted result

Group	Value (mean), T-score	Standard deviation
Cholinesterase Inhibitor Onlyn=11 Participants	82.09	13.52
Cholinesterase Plus Modafiniln=11 Participants	89.09	9.61

Secondary/protocol endpoint

Zarit Burden Inventory

Time frame:at baseline

descriptive

Secondary/protocol endpoint

Zarit Burden Inventory

Time frame:after 8 weeks of treatment

descriptive

Secondary/registry result

Zarit Burden Inventory

Time frame:at baseline

descriptive

Posted result

Group	Value (mean), raw score	Standard deviation
Cholinesterase Inhibitor Onlyn=11 Participants	28.36	21.09
Cholinesterase Plus Modafiniln=11 Participants	31.18	8.73

Secondary/registry result

Zarit Burden Inventory

Time frame:after 8 weeks of treatment

descriptive

Posted result

Group	Value (mean), raw score	Standard deviation
Cholinesterase Inhibitor Onlyn=11 Participants	30.00	20.56
Cholinesterase Plus Modafiniln=11 Participants	30.00	4.17

Publications (1)

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

Frakey LL, Salloway S, Buelow M, Malloy P. A randomized, double-blind, placebo-controlled trial of modafinil for the treatment of apathy in individuals with mild-to-moderate Alzheimer's disease. J Clin Psychiatry. 2012 Jun;73(6):796-801. doi: 10.4088/JCP.10m06708. Epub 2012 May 15.
PMID22687392via DERIVED

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.