Trial · NCT02822573

Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil

NCT02822573, Phase 3, Completed, Wake Forest University Health Sciences; results first posted 2023-09-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil. Trials, record NCT02822573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02822573

On this page

Trial

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

Title: Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil
NCT number: NCT02822573
Status: Completed
Phases: Phase 3
Enrollment: 276 participants, actual
Lead sponsor: Wake Forest University Health Sciences
Conditions: Cognitive Dysfunction, Memory Impairment
Interventions: Donepezil 5 mg, Placebo
First posted: 2016-07-04
Last updated: 2023-09-13
Results first posted: 2023-09-13
Limitations and caveats: Our mainly non-Hispanic, white sample of breast cancer survivors, while geographically diverse, is not representative of all survivors. A lack of validated alternate forms of most of our tests may have contributed to a practice effect. We did not collect estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2) status.

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Hopkins Verbal Learning Test-Revised (HVLT-R) - Total	Baseline, Weeks 12, 24, 36	Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to patients on three successive learning trials. Free recall scores are recorded for each learning trial. After a 20-minute interval during which patients complete other non-interfering tasks and questionnaires they are asked to recall the target words. Range is 0-36 with higher values representing better verbal learning and memory.
Secondary	Digit Symbol Coding Results	Baseline, Weeks 12, 24, 36	The digit symbol coding (DSC) test measures processing speed, working memory, visuospatial processing, and attention. The DSC test measures processing speed. It requires respondents to transcribe symbols (e.g., \>) associated with a number (0-9) into empty boxes beneath a series of randomly ordered numbers. Total score is number of correctly transcribed symbols in 2 minutes. Scores range from 0 to 100, with higher scores indicating higher cognitive function.
Secondary	PROMIS 7-item Fatigue Scale Converted to T-scale Results	Baseline, Weeks 12, 24, 36	This self-report scale assesses fatigue. Scale ranges from 7 to 35 converted to T-scale ranging 29.4 to 83.2 Higher scores representing more fatigue.
Secondary	FACT-Cognition (Version 3): Perceived Cognitive Impairment	Baseline, Weeks 12, 24, 36	The FACT-Cog is a patient-reported outcome (PRO) that includes subscales to measure Perceived Cognitive Impairment (PCI, n = 20 items, score range 0-80). Higher FACT-Cog PCI scores are better and indicate less cognitive impairment.
Secondary	Controlled Oral Word Association Test (COWA) Results	Baseline, Weeks 12, 24, 36	The Controlled Oral Word Association Test from the Halstead-Reitan Neuropsychological Battery is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Scores are the sum of all acceptable words. Minimum is 0 with no specified maximum; higher values represent better verbal fluency.
Secondary	Trail Making Test, Parts A & B (TMT-A, TMT-B) Results	Baseline, Weeks 12, 24, 36	TMT Part A consists of 25 circles on a piece of paper with the numbers 1 to 25 written randomly in each. For Part A, the person is tasked with drawing a line from one circle to the next in ascending numerical order, from 1 to 25, as quickly as possible. The lines between the circles are referred to as the "trail." Range 1-300 in seconds. Lower values indicate completing task faster with less difficulty. It is a measure of executive functioning with lower values being better. TMT Part B also consists of 25 circles on a piece of paper, But, rather than all of the circles containing numbers, they contain numbers (1 to 12) and letters (A through L). For Part B, the person is tasked with connecting the circles in ascending order, alternating back and forth from numbers to letters. In other words, the "trail" would be connected like this:1-A-2-B-3-C-4-D-5-E-6-F-7-G-8-H-9-I-10-J-11-K-12-L-13. The range 1-300 seconds. Higher values indicate worse executive functioning.
Secondary	Digit Span Test-Backwards (DST-B)	Baseline, Weeks 12, 24, 36	The Digit Span Task (Backwards-Only Version) measures working memory. On each question the participant repeats the numbers in reverse order of that presented aloud by the examiner (e.g., If the examiner says "5-6", the correct response would be "6-5"; If the examiner says "5-1-7-4-2-3-8", the correct response would be "8-3-2-4-7-1-5"). Score is 0 to 16 with higher scores representing better working memory.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Hopkins Verbal Learning Test-Revised (HVLT-R) - Total	Baseline, Weeks 12, 24, 36	Intent to treat analysis. Considered and utilized all data available at each timepoint.	score on a scale of 0-36	LEAST_SQUARES_MEAN
SECONDARY	Digit Symbol Coding Results	Baseline, Weeks 12, 24, 36	Intent to treat analysis. All available data from all participants utilized in models.	score on a scale 0-100	LEAST_SQUARES_MEAN
SECONDARY	PROMIS 7-item Fatigue Scale Converted to T-scale Results	Baseline, Weeks 12, 24, 36	Intent to treat: all participants and timepoints available were utilized.	T-score	LEAST_SQUARES_MEAN
SECONDARY	FACT-Cognition (Version 3): Perceived Cognitive Impairment	Baseline, Weeks 12, 24, 36	Intent to treat analyses: all available timepoints and participant data utilized.	score on a scale 0-80	LEAST_SQUARES_MEAN
SECONDARY	Controlled Oral Word Association Test (COWA) Results	Baseline, Weeks 12, 24, 36	Intent to treat analysis. All available timepoints from all participants utilized.	score on a scale 0 to no specified maxim	LEAST_SQUARES_MEAN
SECONDARY	Trail Making Test, Parts A & B (TMT-A, TMT-B) Results	Baseline, Weeks 12, 24, 36	Intent to treat analysis. All available participants and time points utilized.	time (seconds)	LEAST_SQUARES_MEAN
SECONDARY	Digit Span Test-Backwards (DST-B)	Baseline, Weeks 12, 24, 36	Intent to treat analyses: all timepoints and participant data used.	score on a scale 0-16	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group48

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

Outcome	Group	Category	Value	Spread	Units
Hopkins Verbal Learning Test-Revised (HVLT-R) - Total	Donepezil	12 Weeks	24.4	95% Confidence Interval 23.6 to 25.1	score on a scale of 0-36
Hopkins Verbal Learning Test-Revised (HVLT-R) - Total	Placebo	12 Weeks	24.5	95% Confidence Interval 23.7 to 25.3	score on a scale of 0-36
Hopkins Verbal Learning Test-Revised (HVLT-R) - Total	Donepezil	24 Weeks	26.0	95% Confidence Interval 25.2 to 26.8	score on a scale of 0-36
Hopkins Verbal Learning Test-Revised (HVLT-R) - Total	Placebo	24 Weeks	26.5	95% Confidence Interval 25.8 to 27.2	score on a scale of 0-36
Hopkins Verbal Learning Test-Revised (HVLT-R) - Total	Donepezil	36 Weeks	25.1	95% Confidence Interval 24.3 to 25.9	score on a scale of 0-36
Hopkins Verbal Learning Test-Revised (HVLT-R) - Total	Placebo	36 Weeks	25.9	95% Confidence Interval 25.1 to 26.7	score on a scale of 0-36
Digit Symbol Coding Results	Donepezil	12 Weeks	69.6	95% Confidence Interval 67.1 to 72.1	score on a scale 0-100
Digit Symbol Coding Results	Placebo	12 Weeks	67.7	95% Confidence Interval 65.2 to 70.2	score on a scale 0-100
Digit Symbol Coding Results	Donepezil	24 Weeks	71.9	95% Confidence Interval 69.4 to 74.5	score on a scale 0-100
Digit Symbol Coding Results	Placebo	24 Weeks	71.9	95% Confidence Interval 69.4 to 74.4	score on a scale 0-100

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Donepezil	140
Overall Study	STARTED	Placebo	136
Overall Study	COMPLETED	Donepezil	110
Overall Study	COMPLETED	Placebo	117
Overall Study	NOT COMPLETED	Donepezil	30
Overall Study	NOT COMPLETED	Placebo	19

Source ClinicalTrials.gov

Adverse events22

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
serious	Insomnia	Psychiatric disorders	Donepezil	5	140	5
serious	Insomnia	Psychiatric disorders	Placebo	3	136	3
serious	Hypertension	Vascular disorders	Donepezil	2	140	2
serious	Hypertension	Vascular disorders	Placebo	4	136	4
serious	Headache	Nervous system disorders	Donepezil	2	140	2
serious	Headache	Nervous system disorders	Placebo	2	136	2
serious	Apnea	Respiratory, thoracic and mediastinal disorders	Donepezil	0	140	0
serious	Apnea	Respiratory, thoracic and mediastinal disorders	Placebo	1	136	1
serious	Diarrhea	Gastrointestinal disorders	Donepezil	1	140	1
serious	Diarrhea	Gastrointestinal disorders	Placebo	0	136	0

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Donepezil	0	140
Total, all-cause mortality	Placebo	0	136
Total, other adverse events	Donepezil	0	140
Total, other adverse events	Placebo	0	136
Total, serious adverse events	Donepezil	12	140
Total, serious adverse events	Placebo	8	136

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38709986	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
UG1CA189824	Wake Forest NCORP Research Base	LESSER, GLENN J; DRESSLER, EMILY VAN METER; WEAVER, KATHRYN ELIZABETH	WAKE FOREST UNIVERSITY HEALTH SCIENCES	NATIONAL CANCER INSTITUTE	2014 to 2025

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Donepezil vs Placebo: deaths from any cause	Trial comparisons
Donepezil vs Placebo: serious adverse events	Trial comparisons

Tests6

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

Test	Named as	Source
Verbal Learning	Primary outcome	ConductCognition
Digit Span Test	Secondary outcome	ConductCognition
Symbol Coding	Secondary outcome	ConductCognition
Trail Making Test A	Secondary outcome	ConductCognition
Trail Making Test B	Secondary outcome	ConductCognition
Verbal Fluency	Secondary outcome	ConductCognition

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/NCT02822573

GET https://conductscience.org/api/trials/v1/NCT02822573/results?page=2

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