Trial · NCT01670526

Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI

NCT01670526, Phase 3, Completed, VA Office of Research and Development; results first posted 2017-07-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI. Trials, record NCT01670526. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01670526

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Trial

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

Title: Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI
NCT number: NCT01670526
Status: Completed
Phases: Phase 3
Enrollment: 94 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Traumatic Brain Injury, Cognitive Impairment
Interventions: Rivastigmine Transdermal Patch
First posted: 2012-08-22
Last updated: 2018-02-27
Results first posted: 2017-07-25

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Demonstrated Improvement From Baseline on the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall	week 12	The primary efficacy measure was the Hopkins Verbal Learning Test - Revised (HVLT-R) Total Recall Index. HVLT-R was administered at screen, baseline, weeks 4, and 12. The HVLT is a measure that assesses verbal learning and memory. Alternate versions of the HVLT-R were administered at each of the different time points. The test consists of 12 words which are read to participants for three consecutive trials, each trial followed by free recall. The Total Recall score is the total number of words recalled over the three trials. The primary endpoint evaluation was to compare the proportion of patients who demonstrated improvement from baseline on the HVLT-R Total Recall of at least 5-word and at week 12 between the treatment and placebo group.
Secondary	Twelve-week Change in University of California San Diego Performance-based Skills Assessment - Brief (UPSA-B)	12 weeks	UPSA-B is a validated performance-based measure to evaluate the impact of rivastigmine-mediated memory improvements on the ability to perform tasks required for day-to-day functioning in two subdomains of financial management and communication. The scale goes from (0-100) and high score indicates better functions. Comparison of difference in mean changes of UPSA-B from baseline to 12-week follow-up between two groups.
Secondary	Twelve-week Change in The PTSD Symptom Checklist-Military Version (PCL-M)	12 week	PCL-M is a validated 17-item self-report measure of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) symptoms of PTSD.The PCL-M asks about problems in response to "stressful military experiences." Items are rated on a 5-point scale ranging from 1 ("not at all") to 5 ("extremely"). Higher score indicates more stressful. Comparison of difference in mean changes of PCL-M from baseline to 12-week follow-up between two groups.
Secondary	Twelve-week Change in Beck Depression Inventory-II (BDI-II)	12 week	Beck Depression Inventory-II (BDI-II) is a validated 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depressive symptoms. Each answer is scored on a scale value of 0 to 3. Higher score indicates more severe depression. To compare the differences in mean changes of BDI-II between two groups using two groups from baseline to week 12.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Demonstrated Improvement From Baseline on the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall	week 12		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Twelve-week Change in University of California San Diego Performance-based Skills Assessment - Brief (UPSA-B)	12 weeks	Participants complete 12 weeks follow up included in this analysis.	units on a scale	MEAN
SECONDARY	Twelve-week Change in The PTSD Symptom Checklist-Military Version (PCL-M)	12 week		units on a scale	MEAN
SECONDARY	Twelve-week Change in Beck Depression Inventory-II (BDI-II)	12 week		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Number of Participants With Demonstrated Improvement From Baseline on the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall	Rivastigmine	20		Participants
Number of Participants With Demonstrated Improvement From Baseline on the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall	Placebo	23		Participants
Twelve-week Change in University of California San Diego Performance-based Skills Assessment - Brief (UPSA-B)	Rivastigmine	-0.9	Standard Deviation 6.4	units on a scale
Twelve-week Change in University of California San Diego Performance-based Skills Assessment - Brief (UPSA-B)	Placebo	3.3	Standard Deviation 8.5	units on a scale
Twelve-week Change in The PTSD Symptom Checklist-Military Version (PCL-M)	Rivastigmine	-1.4	Standard Deviation 8.9	units on a scale
Twelve-week Change in The PTSD Symptom Checklist-Military Version (PCL-M)	Placebo	-4.4	Standard Deviation 9.8	units on a scale
Twelve-week Change in Beck Depression Inventory-II (BDI-II)	Rivastigmine	-1.4	Standard Deviation 8.8	units on a scale
Twelve-week Change in Beck Depression Inventory-II (BDI-II)	Placebo	-0.7	Standard Deviation 9.2	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Rivastigmine	49
Overall Study	STARTED	Placebo	45
Overall Study	COMPLETED	Rivastigmine	37
Overall Study	COMPLETED	Placebo	39
Overall Study	NOT COMPLETED	Rivastigmine	12
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events56

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	accident at work	Injury, poisoning and procedural complications	Rivastigmine	0	49	0
other	accident at work	Injury, poisoning and procedural complications	Placebo	1	45	1
other	Application site erythema	Skin and subcutaneous tissue disorders	Rivastigmine	1	49	1
other	Application site erythema	Skin and subcutaneous tissue disorders	Placebo	0	45	0
other	application site irritation	Skin and subcutaneous tissue disorders	Rivastigmine	0	49	0
other	application site irritation	Skin and subcutaneous tissue disorders	Placebo	1	45	1
other	Application site pruritus	Skin and subcutaneous tissue disorders	Rivastigmine	1	49	1
other	Application site pruritus	Skin and subcutaneous tissue disorders	Placebo	0	45	0
other	Carpel tunnel syndrome	Musculoskeletal and connective tissue disorders	Rivastigmine	1	49	1
other	Carpel tunnel syndrome	Musculoskeletal and connective tissue disorders	Placebo	0	45	0

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rivastigmine	0	49
Total, all-cause mortality	Placebo	0	45
Total, other adverse events	Rivastigmine	10	49
Total, other adverse events	Placebo	10	45
Total, serious adverse events	Rivastigmine	4	49
Total, serious adverse events	Placebo	4	45

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33514274	DERIVED	PubMed
34213962	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons3

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

Comparison	Source
Rivastigmine vs Placebo: Number of Participants With Demonstrated Improvement From Baseline on the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall	Trial comparisons
Rivastigmine vs Placebo: deaths from any cause	Trial comparisons
Rivastigmine vs Placebo: serious adverse events	Trial comparisons

Tests1

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
Verbal Learning	Primary outcome

Source 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/NCT01670526

GET https://conductscience.org/api/trials/v1/NCT01670526/events?page=2

API reference For AI assistants