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NCT01254448 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Alzheimers Disease, sponsored by Targacept.

Completed
Registry status
Phase 1
Development phase
38
Enrollment target
10
Study locations

NCT01254448 is a Phase 1 study of Alzheimers Disease that has completed, run by Targacept. The registered enrollment target is 38 participants, below the 4,061-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (99% lower). The trial reports 10 study locations across 6 states.

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The verdict

NCT01254448, a Phase 1 study of Alzheimers Disease, has completed, sponsored by Targacept.

COMPLETED
Registry status
Phase 1
Development phase
38 participants
Enrollment target
10
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG TC-5619

Study Locations (10)

Florida

  • MD Clinical - Hallandale
  • Galiz Research - Miami Springs
  • Comprehensive Phase One - Miramar
  • Compass Research, LLC - Orlando

California

  • Collaborative Neuroscience Network - Long Beach
  • San Francisco Clinical Research Center - San Francisco

Georgia

  • Atlanta Center For Clinical Research - Atlanta

New Jersey

  • Princeton Medical Institutes - Princeton

Texas

  • Community Clinical Research - Austin

Utah

  • Aspen Clinical Research - Orem

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2010-09
Est. Completion 2011-05
Phase Phase 1

Sponsor

Targacept

13 total trials

What the Registry Record Tells You About NCT01254448

The ClinicalTrials.gov registry entry for NCT01254448 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,061-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (99% lower). The listed sponsor is Targacept, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01254448 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT01254448 about?

NCT01254448 is a clinical study titled "Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease". 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 incl...

What is the current status of trial NCT01254448?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2010-09. Estimated completion is 2011-05.

What conditions does trial NCT01254448 study?

This clinical trial studies the following conditions: Alzheimers Disease.

What interventions are being tested in trial NCT01254448?

The interventions under investigation include: Placebo (DRUG), TC-5619 (DRUG).

Who is sponsoring clinical trial NCT01254448?

This trial is sponsored by Targacept, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01254448 being conducted?

This trial has 10 study locations across California, Florida, Georgia, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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