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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01361633
First received: May 24, 2011
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Treatment
Placebo
Drug: d-cycloserine
Drug: Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Assesses Sustained Attention

  • 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 ] [ Designated as safety issue: No ]
    Measure of a person's ability to make verbal associations to specified letters.

  • Logical Memory Subtests [ Time Frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up ] [ Designated as safety issue: No ]
    Measures verbal memory recall

  • 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 ] [ Designated as safety issue: No ]
    Assesses executive functioning

  • Tower of London [ Time Frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up ] [ Designated as safety issue: No ]
    Assesses executive functioning

  • Trails B [ Time Frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up ] [ Designated as safety issue: No ]
    Assesses executive functioning

  • Stroop [ Time Frame: Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up ] [ Designated as safety issue: No ]
    Assesses executive functioning

  • 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 ] [ Designated as safety issue: No ]
    Assesses implicit memory for anxious and neutral words


Enrollment: 51
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medication
250 mg d-cycloserine
Drug: d-cycloserine
single oral administration of 250 mg d-cycloserine
Other Name: Seromycin
Placebo Comparator: Sugar Pill Drug: Sugar Pill
Single oral administration 250 mg Sugar Pill
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361633

Locations
United States, Connecticut
Anxiety Disorders Center, Institute of Living/Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Gretchen J. Diefenbach, Ph.D. Hartford Hospital
  More Information

No publications provided

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01361633     History of Changes
Other Study ID Numbers: 126177, DIEF002352HI
Study First Received: May 24, 2011
Results First Received: June 22, 2011
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hartford Hospital:
d-cycloserine
geriatric
neuropsychology
cognition
cognitive-enhancer
aging
neuropsychological functioning

Additional relevant MeSH terms:
Cycloserine
Nootropic Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014