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Nicotine Treatment of Cognitive Decline in Down Syndrome

NCT01778946 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-05-10

Study results available
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Summary

This study will ascertain whether nicotine is safe and tolerable in DS patients, help with dose-ranging of nicotine in DS, look for evidence of enhancements in cognitive functioning, and establish evidence for biological and behavioral correlates of nicotinic stimulation effects. The knowledge gained from the translational aspects of this project may also guide the application of new nicotinic drugs in DS and generate, for the first time, data on the importance of nicotinic receptor changes in the development of cognitive impairment in DS adults.

Hypotheses:

* Transdermal nicotine treatment will be well tolerated out to one month by non-smoking DS patients without significant adverse effects.
* Nicotine will enhance cognitive performance by one month compared to baseline and post-treatment testing.
* Nicotine will enhance functioning detectable by clinician and/or informant ratings (pre-post).

Conditions

Interventions

DRUG

Low Dose Nicotine (7mg)

DRUG

Moderate Dose Nicotine (14mg)

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Paul A Newhouse, MD · Vanderbilt University Dept. of Psychiatry

  • Alexander C Conley, PhD · Vanderbilt University Medical Center Dept. of Psychiatry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01778946 on ClinicalTrials.gov