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The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly

NCT01361633, Phase 2, Completed, Hartford Hospital; results first posted 2012-06-21

Trial 12

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

FieldValueSource
TitleThe Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented ElderlyClinicalTrials.gov
NCT numberNCT01361633ClinicalTrials.gov
StatusCompletedClinicalTrials.gov
PhasesPhase 2ClinicalTrials.gov
Enrollment51 participants, actualClinicalTrials.gov
Lead sponsorHartford HospitalClinicalTrials.gov
ConditionsTreatment, PlaceboClinicalTrials.gov
Interventionsd-cycloserine, Sugar PillClinicalTrials.gov
First posted2011-05-27ClinicalTrials.gov
Last updated2021-02-18ClinicalTrials.gov
Results first posted2012-06-21ClinicalTrials.gov
Limitations and caveats
DCS dosing was 1 hour prior to testing, rather than 4-8; the sample had homogenous cognitive capabilities; repeatedly administering DCS may have enhanced cognitive functioning; the measures may not have adequately tapped hippocampal-based learning.
ClinicalTrials.gov

Registered outcomes 7

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

ListOutcomeTime frameDescriptionSource
PrimaryCalifornia Verbal Learning Test-II (CLVT-II)
Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without patient follow up. Scores for the experimental and control group were compared.
The CLVT-II is an assessment of verbal learning and memory which measures recall and recognition scores, encoding strategies, learning rates and error types. A list learning task with 16 words from 4 semantic categories are read over a series of 5 list presentations. Recall is assessed after learning and at a 20-minute delay. Software produces a report that computes raw and standardized scores. Our dependent variable was the age adjusted t-score for total number of words recalled after 5 trials. A higher score indicated better recall. The maximum possible score was 80 and a minimum was 0.
ClinicalTrials.gov
SecondaryContinuous Performance TestOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Sustained attention was assessed using the Penn version of the Continuous Performance Test. During the CPT the participant responds to a target stimulus (e.g., the letter "A"), while inhibiting responding to distractor stimuli. Reaction time to correct targets (true positives) was used as the dependent variable. Faster reaction times indicate better performance.
ClinicalTrials.gov
SecondaryControlled Oral Word Association TestOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
The Controlled Oral Word Association Test is a measure of the ability to orally generate words to a phonemic cue within a 60-second time interval. Age and education-adjusted t-scores were used as the dependent variable. A T-score of 50 is equal to the mean, with a standard deviation of 10 points. A higher T-score is a more favorable outcome.
ClinicalTrials.gov
SecondaryWisconsin Card Sort TestOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
The Wisconsin Card Sorting Test is a test of rule-learning and conceptual flexibility. The participant is required to learn to sort a series of cards according to one of three principles (color, form or number) based on response feedback. The age-adjusted t-score for total number of errors was used as a dependent variable. A T-score of 50 is equal to the mean, with a standard deviation of 10 points. A higher T-score is a more favorable outcome.
ClinicalTrials.gov
SecondaryTrails BOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Trails B is a measure of cognitive flexibility. The participant alternates sequencing between numbers and letters. An age and education-adjusted t-score for time to complete the exercise was used as the dependent variable. A T-score of 50 is equal to the mean, with a standard deviation of 10 points. A higher T-score is a more favorable outcome.
ClinicalTrials.gov
SecondaryStroopOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
The Stroop Color Word Test is a measure of selective attention and cognitive flexibility. This measure consists of three conditions: word reading, color naming and color-word naming. The interference score (t-score) was used as the dependent variable. A T-score of 50 is equal to the mean, with a standard deviation of 10 points. Higher t-scores represent a more favorable outcome.
ClinicalTrials.gov
SecondaryImplicit Memory TaskOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Participants were presented with 32 stimulus words: 16 neutral and 16 threatening words. After a filler task (crossing out 8's on a sheet of randomized numbers) participants completed a response sheet including the stems for the 32 words presented to participants (primed words) along with stems for the 32 unprimed words. Participants were instructed to write down the first word that came to mind that completes each word stem. The priming effect was determined using the difference score between the correct number of stem completions for primed versus unprimed words. This is a value determined for each participant using the following equation: correct number of stem completions for primed word minus the correct number of stem completions for unprimed words. A larger difference score indicates a stronger implicit memory.
ClinicalTrials.gov

Outcomes 7

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

TypeOutcomeTime framePopulationUnitsMeasured asSource
PRIMARYCalifornia Verbal Learning Test-II (CLVT-II)
Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without patient follow up. Scores for the experimental and control group were compared.
age adjusted t-scoresMEANClinicalTrials.gov
SECONDARYContinuous Performance TestOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-upmillisecondsMEANClinicalTrials.gov
SECONDARYControlled Oral Word Association TestOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-upt-scoresMEANClinicalTrials.gov
SECONDARYWisconsin Card Sort TestOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-upsample size for DCS group is n = 18 owing to missing data from one participant.t scoresMEANClinicalTrials.gov
SECONDARYTrails BOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-upt-scoresMEANClinicalTrials.gov
SECONDARYStroopOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-upt-scoreMEANClinicalTrials.gov
SECONDARYImplicit Memory TaskOutcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-upcorrect stem completionsMEANClinicalTrials.gov

Results by group 14

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

OutcomeGroupCategoryValueSpreadUnitsSource
California Verbal Learning Test-II (CLVT-II)Medication55.84Standard Deviation 10.37age adjusted t-scoresClinicalTrials.gov
California Verbal Learning Test-II (CLVT-II)Sugar Pill55.39Standard Deviation 10.73age adjusted t-scoresClinicalTrials.gov
Continuous Performance TestMedication479.50Standard Deviation 42.43millisecondsClinicalTrials.gov
Continuous Performance TestSugar Pill507.80Standard Deviation 77.83millisecondsClinicalTrials.gov
Controlled Oral Word Association TestMedication49.58Standard Deviation 9.31t-scoresClinicalTrials.gov
Controlled Oral Word Association TestSugar Pill46.91Standard Deviation 8.14t-scoresClinicalTrials.gov
Wisconsin Card Sort TestMedication53.50Standard Deviation 12.37t scoresClinicalTrials.gov
Wisconsin Card Sort TestSugar Pill53.70Standard Deviation 10.73t scoresClinicalTrials.gov
Trails BMedication52.16Standard Deviation 10.99t-scoresClinicalTrials.gov
Trails BSugar Pill48.83Standard Deviation 9.38t-scoresClinicalTrials.gov
StroopMedication44.68Standard Deviation 7.17t-scoreClinicalTrials.gov
StroopSugar Pill43.30Standard Deviation 6.67t-scoreClinicalTrials.gov
Implicit Memory TaskMedication3.16Standard Deviation 3.24correct stem completionsClinicalTrials.gov
Implicit Memory TaskSugar Pill2.00Standard Deviation 3.43correct stem completionsClinicalTrials.gov

Participant flow 6

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

PeriodMilestoneGroupParticipantsUnits countedSource
Overall StudySTARTEDMedication25ClinicalTrials.gov
Overall StudySTARTEDSugar Pill26ClinicalTrials.gov
Overall StudyCOMPLETEDMedication19ClinicalTrials.gov
Overall StudyCOMPLETEDSugar Pill23ClinicalTrials.gov
Overall StudyNOT COMPLETEDMedication6ClinicalTrials.gov
Overall StudyNOT COMPLETEDSugar Pill3ClinicalTrials.gov

Adverse events 6

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

TypeEventOrgan systemGroupAffectedAt riskEventsSource
otherDrowsinessGeneral disordersMedication2192ClinicalTrials.gov
otherDrowsinessGeneral disordersSugar Pill4234ClinicalTrials.gov
otherTingling sensationGeneral disordersMedication0190ClinicalTrials.gov
otherTingling sensationGeneral disordersSugar Pill1231ClinicalTrials.gov
otherFeeling lightheadedGeneral disordersMedication1191ClinicalTrials.gov
otherFeeling lightheadedGeneral disordersSugar Pill0230ClinicalTrials.gov

Adverse event totals 6

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource
Total, all-cause mortalityMedicationClinicalTrials.gov
Total, all-cause mortalitySugar PillClinicalTrials.gov
Total, other adverse eventsMedication319ClinicalTrials.gov
Total, other adverse eventsSugar Pill423ClinicalTrials.gov
Total, serious adverse eventsMedication019ClinicalTrials.gov
Total, serious adverse eventsSugar Pill023ClinicalTrials.gov

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource

Grants 0

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 1

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

ComparisonSource
Medication vs Sugar Pill: serious adverse eventsTrial comparisons

Tests 6

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

TestNamed asSource
Verbal LearningPrimary outcomeConductCognition
Card Sorting Test (Berg)Secondary outcomeConductCognition
Continuous Performance TestSecondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition
Trail Making Test BSecondary outcomeConductCognition
Verbal FluencySecondary outcomeConductCognition

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)