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.
| Field | Value | Source |
|---|---|---|
| Title | The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly | ClinicalTrials.gov |
| NCT number | NCT01361633 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 51 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Hartford Hospital | ClinicalTrials.gov |
| Conditions | Treatment, Placebo | ClinicalTrials.gov |
| Interventions | d-cycloserine, Sugar Pill | ClinicalTrials.gov |
| First posted | 2011-05-27 | ClinicalTrials.gov |
| Last updated | 2021-02-18 | ClinicalTrials.gov |
| Results first posted | 2012-06-21 | ClinicalTrials.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.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | California 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 |
| Secondary | Continuous Performance Test | Outcome 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 |
| Secondary | Controlled Oral Word Association Test | Outcome 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 |
| Secondary | Wisconsin Card Sort Test | Outcome 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 |
| Secondary | Trails B | Outcome 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 |
| Secondary | Stroop | Outcome 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 |
| Secondary | Implicit Memory Task | Outcome 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.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | California 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-scores | MEAN | ClinicalTrials.gov | |
| SECONDARY | Continuous Performance Test | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up | milliseconds | MEAN | ClinicalTrials.gov | |
| SECONDARY | Controlled Oral Word Association Test | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up | t-scores | MEAN | ClinicalTrials.gov | |
| SECONDARY | Wisconsin Card Sort Test | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up | sample size for DCS group is n = 18 owing to missing data from one participant. | t scores | MEAN | ClinicalTrials.gov |
| SECONDARY | Trails B | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up | t-scores | MEAN | ClinicalTrials.gov | |
| SECONDARY | Stroop | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up | t-score | MEAN | ClinicalTrials.gov | |
| SECONDARY | Implicit Memory Task | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up | correct stem completions | MEAN | ClinicalTrials.gov |
Results by group 14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| California Verbal Learning Test-II (CLVT-II) | Medication | 55.84 | Standard Deviation 10.37 | age adjusted t-scores | ClinicalTrials.gov | |
| California Verbal Learning Test-II (CLVT-II) | Sugar Pill | 55.39 | Standard Deviation 10.73 | age adjusted t-scores | ClinicalTrials.gov | |
| Continuous Performance Test | Medication | 479.50 | Standard Deviation 42.43 | milliseconds | ClinicalTrials.gov | |
| Continuous Performance Test | Sugar Pill | 507.80 | Standard Deviation 77.83 | milliseconds | ClinicalTrials.gov | |
| Controlled Oral Word Association Test | Medication | 49.58 | Standard Deviation 9.31 | t-scores | ClinicalTrials.gov | |
| Controlled Oral Word Association Test | Sugar Pill | 46.91 | Standard Deviation 8.14 | t-scores | ClinicalTrials.gov | |
| Wisconsin Card Sort Test | Medication | 53.50 | Standard Deviation 12.37 | t scores | ClinicalTrials.gov | |
| Wisconsin Card Sort Test | Sugar Pill | 53.70 | Standard Deviation 10.73 | t scores | ClinicalTrials.gov | |
| Trails B | Medication | 52.16 | Standard Deviation 10.99 | t-scores | ClinicalTrials.gov | |
| Trails B | Sugar Pill | 48.83 | Standard Deviation 9.38 | t-scores | ClinicalTrials.gov | |
| Stroop | Medication | 44.68 | Standard Deviation 7.17 | t-score | ClinicalTrials.gov | |
| Stroop | Sugar Pill | 43.30 | Standard Deviation 6.67 | t-score | ClinicalTrials.gov | |
| Implicit Memory Task | Medication | 3.16 | Standard Deviation 3.24 | correct stem completions | ClinicalTrials.gov | |
| Implicit Memory Task | Sugar Pill | 2.00 | Standard Deviation 3.43 | correct stem completions | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Medication | 25 | ClinicalTrials.gov | |
| Overall Study | STARTED | Sugar Pill | 26 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Medication | 19 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Sugar Pill | 23 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Medication | 6 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Sugar Pill | 3 | ClinicalTrials.gov |
Adverse events 6
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 | Source |
|---|---|---|---|---|---|---|---|
| other | Drowsiness | General disorders | Medication | 2 | 19 | 2 | ClinicalTrials.gov |
| other | Drowsiness | General disorders | Sugar Pill | 4 | 23 | 4 | ClinicalTrials.gov |
| other | Tingling sensation | General disorders | Medication | 0 | 19 | 0 | ClinicalTrials.gov |
| other | Tingling sensation | General disorders | Sugar Pill | 1 | 23 | 1 | ClinicalTrials.gov |
| other | Feeling lightheaded | General disorders | Medication | 1 | 19 | 1 | ClinicalTrials.gov |
| other | Feeling lightheaded | General disorders | Sugar Pill | 0 | 23 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Medication | ClinicalTrials.gov | ||
| Total, all-cause mortality | Sugar Pill | ClinicalTrials.gov | ||
| Total, other adverse events | Medication | 3 | 19 | ClinicalTrials.gov |
| Total, other adverse events | Sugar Pill | 4 | 23 | ClinicalTrials.gov |
| Total, serious adverse events | Medication | 0 | 19 | ClinicalTrials.gov |
| Total, serious adverse events | Sugar Pill | 0 | 23 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Medication vs Sugar Pill: serious adverse events | Trial 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.
| Test | Named as | Source |
|---|---|---|
| Verbal Learning | Primary outcome | ConductCognition |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
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)