TreatmentPhase 2NCT01361633
The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly
A Phase 2 study testing d-cycloserine and Sugar Pill in people with Treatment and Placebo, run by Hartford Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- What is being tested?
- d-cycloserine and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Feb 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 60 or older
- native English speaker
Who cannot join
- diagnosis of current psychiatric disorder
- substance abuse past 3 months
- cognitive impairment
- neurological disorder
- poor health or unstable medical condition
- positive toxicology screen
Show all 9Show fewer
- current use of isoniazid
- current use of trecator
- severe renal insufficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety Disorders Center, Institute of Living/Hartford Hospital
Hartford, Connecticut, 06106
About this study
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.
Read the detailed description
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.
- Being tested
- d-cycloserine, Sugar Pill
- Keywords
- d-cycloserine, geriatric, neuropsychology, cognition, cognitive-enhancer, aging, neuropsychological functioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-cycloserineDrug
Also called Seromycin
single oral administration of 250 mg d-cycloserine
Sugar PillDrug
Also called Placebo
Single oral administration 250 mg Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| Medication | Experimental | 250 mg d-cycloserine Receives: Drug: d-cycloserine |
| Sugar Pill | Placebo comparator | Not described Receives: Drug: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (6)
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.
Measured: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJan 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gretchen J. Diefenbach, Ph.D., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361633
- Sponsor's protocol ID
- 126177
- Other IDs
- DIEF002352HI
- Status last verified
- Oct 2019
- First submitted
- 24 May 2011
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly
- ClinicalTrials.gov ID
- NCT01361633
- Acronym / sponsor ID
- 126177
- Keywords
- d-cycloserine, geriatric, neuropsychology, cognition, cognitive-enhancer, aging, neuropsychological functioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Posted 21 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication | Experimental | Drug: d-cycloserine250 mg d-cycloserine |
| Sugar Pill | Placebo comparator | Drug: Sugar Pill |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 60 or older
- native English speaker
Key exclusion criteria (9 listed)
- diagnosis of current psychiatric disorder
- substance abuse past 3 months
- cognitive impairment
- neurological disorder
- poor health or unstable medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| d-cycloserineAlso: Seromycinsingle oral administration of 250 mg d-cycloserine | Drug | Medication |
| Sugar PillAlso: PlaceboSingle oral administration 250 mg Sugar Pill | Drug | Sugar Pill |
Primary outcome
California Verbal Learning Test-II (CLVT-II)
Time frame: 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.
6 secondary outcomes
Continuous Performance Test
Time frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Controlled Oral Word Association Test
Time frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Wisconsin Card Sort Test
Time frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Trails B
Time frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Stroop
Time frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Implicit Memory Task
Time frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen J. Diefenbach, Ph.D. principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing d-cycloserine and Sugar Pill in people with Treatment and Placebo, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
California Verbal Learning Test-II (CLVT-II) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.