Trial · NCT02240589

Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury

NCT02240589, Not applicable, Completed, Indiana University; results first posted 2017-08-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury. Trials, record NCT02240589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02240589

On this page

Trial

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

Title: Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
NCT number: NCT02240589
Status: Completed
Phases: Not applicable
Enrollment: 11 participants, actual
Lead sponsor: Indiana University
Conditions: Traumatic Brain Injury
Interventions: Memantine, Placebo
First posted: 2014-09-15
Last updated: 2017-08-30
Results first posted: 2017-08-30
Limitations and caveats: Small sample size.

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall	Week 24	Neuropsychological test used to assess an individual's verbal memory abilities. The California Verbal Learning Test-Second Edition (CVLT-II) Long Delay Free Recall measures total word list items recalled after a 20-minute delay. The raw score is converted to a Z-score (Mean=0; SD=1) which was used for statistical analysis. Higher scores reflect worse performance (i.e., more recall errors) on this variable.
Secondary	CVLT-II Trials 1-5 Free Recall Total	Week 24	Neuropsychological test used to assess an individual's verbal memory abilities. California Verbal Learning Test-Second Edition (CVLT-II) Trials 1-5 Free Recall Total measures the sum of all word list items correctly recalled on learning trials 1 through 5. This raw score is converted to a T-score (Mean=50; SD=10) which was used for statistical analysis. The total A1-5T score reflects accurate recall over the five learning trials of the first list, and is most often used as a summary index of learning on the CVLT-II, with higher scores reflecting better performance.
Secondary	Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall	Week 24	Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall measures the correctly recalled designs (i.e., standard scoring of accuracy and location as described in the manual) after a 25 minute delay. The delayed recall raw score ranges from 0 to 12 with 12 being the highest and best possible score. The raw score is converted to a T-score (Mean=50; SD=10) which was used for statistical analysis.
Secondary	BVMT-R Learning	Week 24	Brief Visuospatial Memory Test-Revised (BVMT-R) Learning measures the correctly recalled designs (i.e., standard scoring of accuracy and location as described in the manual) over 3 learning trials. The Learning raw score is the sum of the higher number of correctly recalled designs on either Trial 2 or Trial 3 minus the number of correctly recalled designs on Trial 1. A higher score is a better score. The raw score was converted to a T-score (Mean=50; SD=10) for analysis.
Secondary	Trail Making Part B	Week 24	Neuropsychological test of visual attention and executive functioning. The trail making tests are thought to reflect a variety of cognitive processes including attention, visual search and scanning, sequencing and shifting, psychomotor speed, abstraction, flexibility, ability to execute and modify a plan of action, and ability to maintain two trains of thought simultaneously. In Trails B, the participant is instructed to draw lines to connect numbers and letters in an alternating numeric and alphabetic sequence as rapidly as possible. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part B. This is a timed test and the number of seconds to complete the task is recorded. The unit of measure in seconds is converted to a scaled score (mean =10, SD = 3) using the Heaton et al. norms with lower scores indicating better performance.
Secondary	Stroop Interference	Week 24	Stroop Interference Test is a neuropsychological test to assess a person's executive function. Specifically, the test is thought to reflect selective attention, cognitive flexibility and processing speed. The raw score for this measure is the number of items correctly identified within 45 seconds. The raw score was converted to a T-score (mean=50; SD=10) for analysis. Higher scores reflect better performance and less interference on reading ability.
Secondary	Behavior Rating Inventory of Executive Function (BRIEF) Inhibit	Week 24	The Behavior Rating Inventory of Executive Function (BRIEF) Inhibit subscale is a rating scale completed by the participant and independently by an observer that assesses the ability to control impulses (inhibitory control) and to stop engaging in a behavior. The frequency of behaviors indicated by items is rated on a 3-point scale (never, sometimes, often). The raw score for the Inhibit subscale is the sum of ratings for the 8 items included in this measure. This sum was converted to a T-score (mean=50; SD=10) for analysis. Higher scores suggest a higher level of dysfunction in a specific domain of executive functions.
Secondary	Traumatic Brain Injury Quality of Life Anger (TBI QOL Anger)	Week 24	The TBI-QOL Anger item bank includes 38 hierarchically ordered items designed to measure the full continuum of anger in a way which is both sensitive and appropriate for TBI. The TBI-QOL Anger item bank can be administered as a computer-adaptive test (CAT), allowing precise measurement of self-reported anger using only 4-8 adaptively selected items. Using CAT technology, an individual participant's responses to the TBIQoL Anger scale generated a T-score (Mean=50; SD=10) with a range of 0 (lowest anger) to 100 (greatest anger).

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall	Week 24	z-score	MEAN
SECONDARY	CVLT-II Trials 1-5 Free Recall Total	Week 24	t-score	MEAN
SECONDARY	Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall	Week 24	t-score	MEAN
SECONDARY	BVMT-R Learning	Week 24	t-score	MEAN
SECONDARY	Trail Making Part B	Week 24	scaled score	MEAN
SECONDARY	Stroop Interference	Week 24	t-score	MEAN
SECONDARY	Behavior Rating Inventory of Executive Function (BRIEF) Inhibit	Week 24	t-score	MEAN
SECONDARY	Traumatic Brain Injury Quality of Life Anger (TBI QOL Anger)	Week 24	scaled 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
California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall	Memantine	-2.000	Standard Deviation 1.000	z-score
California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall	Placebo	-1.375	Standard Deviation 2.016	z-score
CVLT-II Trials 1-5 Free Recall Total	Memantine	31.000	Standard Deviation 10.817	t-score
CVLT-II Trials 1-5 Free Recall Total	Placebo	37.250	Standard Deviation 15.262	t-score
Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall	Memantine	47.00	Standard Deviation 4.583	t-score
Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall	Placebo	45.50	Standard Deviation 11.561	t-score
BVMT-R Learning	Memantine	60.00	Standard Deviation 8.266	t-score
BVMT-R Learning	Placebo	46.50	Standard Deviation 1.000	t-score
Trail Making Part B	Memantine	11.67	Standard Deviation 6.351	scaled score
Trail Making Part B	Placebo	13.25	Standard Deviation 4.349	scaled 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	Memantine	5
Overall Study	STARTED	Placebo	6
Overall Study	COMPLETED	Memantine	3
Overall Study	COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Memantine	2
Overall Study	NOT COMPLETED	Placebo	2

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	Intracranial hypertension	Nervous system disorders	Memantine	1	5	1
other	Intracranial hypertension	Nervous system disorders	Placebo	0	6	0
other	Pneumonia	Infections and infestations	Memantine	3	5	3
other	Pneumonia	Infections and infestations	Placebo	3	6	3
other	Conjuectivitis	Infections and infestations	Memantine	1	5	1
other	Conjuectivitis	Infections and infestations	Placebo	0	6	0
other	Wound infection	Infections and infestations	Memantine	0	5	0
other	Wound infection	Infections and infestations	Placebo	1	6	1
other	Other, infection	Infections and infestations	Memantine	0	5	0
other	Other, infection	Infections and infestations	Placebo	2	6	2

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	Memantine	0	5
Total, all-cause mortality	Placebo	1	6
Total, other adverse events	Memantine	5	5
Total, other adverse events	Placebo	6	6
Total, serious adverse events	Memantine	0	5
Total, serious adverse events	Placebo	1	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

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

Tests4

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
Stroop Color-Word Test	Secondary outcome	ConductCognition
Trail Making Test A	Secondary outcome	ConductCognition
Trail Making Test B	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/NCT02240589

GET https://conductscience.org/api/trials/v1/NCT02240589/events?page=2

API reference For AI assistants