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Completed Phase 1Phase 2 Interventional Results available

Nicotine Treatment of Cognitive Decline in Down Syndrome

ClinicalTrials.gov ID: NCT01778946

Public ClinicalTrials.gov record NCT01778946. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Nicotinic Treatment of Age-Related Cognitive Decline in Down Syndrome: An Open Label Pilot Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT01778946
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
7 participants

Conditions and interventions

Eligibility (public fields only)

Age range
25 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2013
Primary completion
Jan 31, 2021
Completion
Jan 31, 2021
Last update posted
May 9, 2022

2013 – 2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Vanderbilt Psychiatric Hospital Nashville Tennessee 37212

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01778946, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 9, 2022 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01778946 live on ClinicalTrials.gov.

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