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| ID | Type | Description | Link |
|---|---|---|---|
| DIEF002352HI | Other Grant/Funding Number | Hartford Hospital |
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The goal of this study is to determine whether a study medication (d-cycloserine) improves the ability of older adults to perform on tests of neuropsychological functioning. Tests of neuropsychological functioning assess attention, memory, and executive functioning skills (for example, problem-solving, planning and organizing skills). It was hypothesized that participants who received study medication would perform better on neuropsychological tests than would participants who received the sugar pill.
Accumulating data support the augmenting effects of d-cycloserine (DCS) when combined with exposure-based treatment for anxiety disorders. Additional research is needed to determine whether DCS facilitates other forms of cognitive processing (e.g., attention, memory, executive functioning) that are involved in cognitive behavioral therapies which do not rely on extinction as a mechanism of action. This question is particularly important among older adults who have experienced normal age-related declines in cognitive functioning, which may interfere with their ability to benefit from cognitive-behavioral therapies. The aim of the current study was to determine the cognitive enhancing effects of DCS on neuropsychological test performance among healthy older adults. It was hypothesized that participants who received d-cycloserine would demonstrate superior performance on neuropsychological tests than would participants who received placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication | Experimental | 250 mg d-cycloserine |
|
| Sugar Pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d-cycloserine | Drug | single oral administration of 250 mg d-cycloserine |
|
| Measure | Description | Time Frame |
|---|---|---|
| California Verbal Learning Test-II (CLVT-II) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Performance Test | 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. | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen J. Diefenbach, Ph.D. | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anxiety Disorders Center, Institute of Living/Hartford Hospital | Hartford | Connecticut | 06106 | United States |
Participants were excluded at Baseline if they had abnormal lab results (6), were taking Aricept (1), were too worried about taking medication (1), or had concurrent depression (1).
Inclusion criteria:
Exclusion criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Medication | 250 mg d-cycloserine |
| FG001 | Sugar Pill | Placebo Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medication | 250 mg d-cycloserine |
| BG001 | Sugar Pill | Placebo Control |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | California Verbal Learning Test-II (CLVT-II) | 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. | Posted | Mean | Standard Deviation | age adjusted t-scores | 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. |
|
Adverse events were monitored via a standardized side effect check list in the one hour time frame after the single dose administration and prior to neuropsychological testing. No spontaneous adverse events outside of this time frame were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medication | 250 mg d-cycloserine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | General disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gretchen Diefenbach, Ph.D. | Anxiety Disorders Center, Institute of Living/Hartford Hospital | 860-545-7685 | 5-7396 | gdiefen@harthosp.org |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sugar Pill | Drug | Single oral administration 250 mg Sugar Pill |
|
|
| Controlled Oral Word Association Test | 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. | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
| Wisconsin Card Sort Test | 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. | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
| Trails B | 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. | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
| Stroop | 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. | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
| Implicit Memory Task | 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. | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sugar Pill | Placebo control |
|
|
| Secondary | Continuous Performance Test | 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. | Posted | Mean | Standard Deviation | milliseconds | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
|
|
| Secondary | Controlled Oral Word Association Test | 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. | Posted | Mean | Standard Deviation | t-scores | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
|
|
| Secondary | Wisconsin Card Sort Test | 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. | sample size for DCS group is n = 18 owing to missing data from one participant. | Posted | Mean | Standard Deviation | t scores | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
|
|
| Secondary | Trails B | 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. | Posted | Mean | Standard Deviation | t-scores | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
|
|
| Secondary | Stroop | 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. | Posted | Mean | Standard Deviation | t-score | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
|
|
| Secondary | Implicit Memory Task | 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. | Posted | Mean | Standard Deviation | correct stem completions | Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up |
|
|
|
| 0 |
| 19 |
| 3 |
| 19 |
| EG001 | Sugar Pill | Placebo Control | 0 | 23 | 4 | 23 |
| Tingling sensation | General disorders | Systematic Assessment |
|
| Feeling lightheaded | General disorders | Systematic Assessment |
|
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |