Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
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.
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
- Enrollment
- 38 participants
Conditions and interventions
Conditions
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
- Aug 31, 2010
- Primary completion
- Feb 28, 2011
- Completion
- Apr 30, 2011
- Last update posted
- Sep 3, 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 3, 2013 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01254448 live on ClinicalTrials.gov.