Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01361633
Other study ID # 126177
Secondary ID DIEF002352HI
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2008
Est. completion date February 2009

Study information

Verified date October 2019
Source Hartford Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - age 60 or older - native English speaker Exclusion Criteria: - diagnosis of current psychiatric disorder - substance abuse past 3 months - cognitive impairment - neurological disorder - poor health or unstable medical condition - positive toxicology screen - current use of isoniazid - current use of trecator - severe renal insufficiency

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
d-cycloserine
single oral administration of 250 mg d-cycloserine
Sugar Pill
Single oral administration 250 mg Sugar Pill

Locations

Country Name City State
United States Anxiety Disorders Center, Institute of Living/Hartford Hospital Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 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 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
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. 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. 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. 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. 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. Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT05243134 - The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
Completed NCT02486874 - Clinical Evaluation of PoreSkin Phase 1
Active, not recruiting NCT04592640 - Stem Cells for Uremic Calciphylaxis Patients N/A
Recruiting NCT04599686 - Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer N/A
Recruiting NCT03351842 - Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20% Phase 2
Completed NCT03439930 - The Effect of Balance Training on Neuromuscular Control in Subjects With CAI N/A
Completed NCT02782442 - Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM) N/A
Not yet recruiting NCT05537155 - Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery N/A
Recruiting NCT02971982 - PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia Phase 1/Phase 2
Completed NCT02820272 - Water for Reducing Pain in Negative Pressure Wound Therapy Phase 2
Completed NCT00984958 - Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure N/A
Completed NCT00575224 - Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9 Phase 4
Completed NCT00164307 - Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships Phase 1/Phase 2
Completed NCT00164528 - Intervening With Children/Adolescents With FAS/ARND Phase 1/Phase 2
Recruiting NCT04603586 - Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses N/A
Recruiting NCT03375424 - Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany N/A
Not yet recruiting NCT04062370 - Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion Phase 4
Not yet recruiting NCT02931136 - Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging Phase 4
Completed NCT04661228 - Diagnostic Survey of Mental and Substance Use Disorders in HUNT (PsykHUNT)
Recruiting NCT03365141 - Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo N/A