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

NCT01361633 | Completed Phase 2 Results

• 2 other identifiers: 126177DIEF002352HI
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment; Placebo

Keywords

d-cycloserine; geriatric; neuropsychology; cognition; cognitive-enhancer; aging; neuropsychological functioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Continuous Performance Test

  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

  Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up

• Wisconsin Card Sort Test

  Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up

• Trails B

  Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up

• Stroop

  Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up

Study Arms (2)

Medication

EXPERIMENTAL

250 mg d-cycloserine

Drug: d-cycloserine

Sugar Pill

PLACEBO COMPARATOR

Drug: Sugar Pill

Interventions

d-cycloserine DRUG

single oral administration of 250 mg d-cycloserine

Also known as: Seromycin

Medication

Sugar Pill DRUG

Single oral administration 250 mg Sugar Pill

Also known as: Placebo

Sugar Pill

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 60 or older
• native English speaker

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Anxiety Disorders Center, Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Interventions

Cycloserine; Sugars

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

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.

Results Point of Contact

• Title: Gretchen Diefenbach, Ph.D.
• Organization: Anxiety Disorders Center, Institute of Living/Hartford Hospital

gdiefen@harthosp.org

860-545-7685

Study Officials

• Gretchen J. Diefenbach, Ph.D.

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 27, 2011
• Study Start: January 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 18, 2021
• Results First Posted: June 21, 2012

Record last verified: 2019-10

Locations

US (1)