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Completed Phase 1 Interventional Accepts healthy volunteers

Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease

ClinicalTrials.gov ID: NCT01254448

Public ClinicalTrials.gov record NCT01254448. 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 Oct 24, 2026, 4:24 AM EDT

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

Official title

Two-Part, Sequential Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TC-5619-238 in Elderly Subjects With and Without Alzheimer's Disease

Brief summary

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

This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.

Study identification

NCT ID
NCT01254448
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Targacept Inc.
Industry
Enrollment
38 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
55 Years to 80 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

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

Study timeline

Start date
Sep 2010 (Type not available)
Primary completion
Mar 2011 (Actual)
Completion
May 2011 (Actual)
Last update posted
Sep 4, 2013

2010 – 2011

United States locations

U.S. sites
10
U.S. states
6
U.S. cities
10
Facility City State ZIP Site status
Collaborative Neuroscience Network Long Beach California 90806 —
San Francisco Clinical Research Center San Francisco California 94109 —
MD Clinical Hallandale Florida 33009 —
Galiz Research Miami Springs Florida 33166 —
Comprehensive Phase One Miramar Florida 333025 —
Compass Research, LLC Orlando Florida 32806 —
Atlanta Center For Clinical Research Atlanta Georgia 30308 —
Princeton Medical Institutes Princeton New Jersey 08540 —
Community Clinical Research Austin Texas 78754 —
Aspen Clinical Research Orem Utah 84058 —

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 NCT01254448, 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 Sep 4, 2013 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01254448 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →