Trial · NCT01172145

Treatment of Apathy in Alzheimer's Disease With Modafinil

NCT01172145, Phase 3, Completed, Brown University; results first posted 2011-03-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Apathy in Alzheimer's Disease With Modafinil. Trials, record NCT01172145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01172145

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treatment of Apathy in Alzheimer's Disease With Modafinil
NCT number: NCT01172145
Status: Completed
Phases: Phase 3
Enrollment: 22 participants, actual
Lead sponsor: Brown University
Conditions: Apathy, Alzheimer's Disease
Interventions: Modafinil, Placebo
First posted: 2010-07-29
Last updated: 2011-03-04
Results first posted: 2011-03-04

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Apathy	at baseline	The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
Primary	Apathy	after 8 weeks of treatment	The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
Secondary	Lawton Brody Activities of Daily Living Questionnaire	at baseline	Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
Secondary	The Direct Assessment of Functional Status Scale	at baseline	A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
Secondary	Zarit Burden Inventory	at baseline	Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.
Secondary	Lawton Brody Activities of Daily Living Questionnaire	after 8 weeks of treatment	Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
Secondary	The Direct Assessment of Functional Status Scale	after 8 weeks of treatment	A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
Secondary	Zarit Burden Inventory	after 8 weeks of treatment	Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Apathy	at baseline	T-score	MEAN
PRIMARY	Apathy	after 8 weeks of treatment	T-score	MEAN
SECONDARY	Lawton Brody Activities of Daily Living Questionnaire	at baseline	raw score	MEAN
SECONDARY	The Direct Assessment of Functional Status Scale	at baseline	raw score	MEAN
SECONDARY	Zarit Burden Inventory	at baseline	raw score	MEAN
SECONDARY	Lawton Brody Activities of Daily Living Questionnaire	after 8 weeks of treatment	raw score	MEAN
SECONDARY	The Direct Assessment of Functional Status Scale	after 8 weeks of treatment	raw score	MEAN
SECONDARY	Zarit Burden Inventory	after 8 weeks of treatment	raw score	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Apathy	Cholinesterase Inhibitor Only	88.91	Standard Deviation 11.95	T-score
Apathy	Cholinesterase Plus Modafinil	95.64	Standard Deviation 10.79	T-score
Apathy	Cholinesterase Inhibitor Only	82.09	Standard Deviation 13.52	T-score
Apathy	Cholinesterase Plus Modafinil	89.09	Standard Deviation 9.61	T-score
Lawton Brody Activities of Daily Living Questionnaire	Cholinesterase Inhibitor Only	19.00	Standard Deviation 5.25	raw score
Lawton Brody Activities of Daily Living Questionnaire	Cholinesterase Plus Modafinil	16.18	Standard Deviation 4.81	raw score
The Direct Assessment of Functional Status Scale	Cholinesterase Inhibitor Only	89.09	Standard Deviation 7.84	raw score
The Direct Assessment of Functional Status Scale	Cholinesterase Plus Modafinil	84.55	Standard Deviation 16.11	raw score
Zarit Burden Inventory	Cholinesterase Inhibitor Only	28.36	Standard Deviation 21.09	raw score
Zarit Burden Inventory	Cholinesterase Plus Modafinil	31.18	Standard Deviation 8.73	raw score

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cholinesterase Inhibitor Only	11
Overall Study	STARTED	Cholinesterase Plus Modafinil	11
Overall Study	COMPLETED	Cholinesterase Inhibitor Only	11
Overall Study	COMPLETED	Cholinesterase Plus Modafinil	11
Overall Study	NOT COMPLETED	Cholinesterase Inhibitor Only	0
Overall Study	NOT COMPLETED	Cholinesterase Plus Modafinil	0

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Motor Tics	Nervous system disorders	Cholinesterase Inhibitor Only	0	11	0
other	Motor Tics	Nervous system disorders	Cholinesterase Plus Modafinil	1	11	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cholinesterase Inhibitor Only
Total, all-cause mortality	Cholinesterase Plus Modafinil
Total, other adverse events	Cholinesterase Inhibitor Only	0	11
Total, other adverse events	Cholinesterase Plus Modafinil	1	11
Total, serious adverse events	Cholinesterase Inhibitor Only	0	11
Total, serious adverse events	Cholinesterase Plus Modafinil	0	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22687392	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
F32MH075583	Treatment of apathy in Alzheimer's disease with modafinil	FRAKEY, LAURA L	BROWN UNIVERSITY	NATIONAL INSTITUTE OF MENTAL HEALTH	2005 to 2006

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Cholinesterase Inhibitor Only vs Cholinesterase Plus Modafinil: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01172145

GET https://conductscience.org/api/trials/v1/NCT01172145/registered

API reference For AI assistants