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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254448
• Other study ID #: TC-5619-238-CLP-003
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2010
• Last updated: September 3, 2013
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: September 2013
• Source: Targacept Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria (Groups 1 & 2):

• Normal body mass index (BMI)

• Non-smoking for a minimum of 3 months

• Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG.

Group 1 Only:

• Subjects a Mini Mental State Examination score between 12-22, inclusive.

• Diagnosis of probable Alzheimer's Disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

• Subjects must have a reliable caregiver.

Exclusion Criteria (Groups 1 & 2):

• Subjects with clinically significant heart disease, pulmonary disease, diabetes, neurologic or psychiatric disease (Group 1 subjects must have Alzheimer's Disease), or any other illness that could interfere with interpretation of study results.

• Subjects with a past or current history of seizures cannot participate.

• Current use of donepezil, rivastigmine or galantamine.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• TC-5619
Group 1: 25 mg TC-5619 administered once daily for 28 days. Group 2: 50-150 mg TC-5619 administered once daily for 10 days.
• Placebo
Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.

Locations

Country	Name	City	State
United States	Atlanta Center For Clinical Research	Atlanta	Georgia
United States	Community Clinical Research	Austin	Texas
United States	MD Clinical	Hallandale Beach	Florida
United States	Collaborative Neuroscience Network	Long Beach	California
United States	Galiz Research	Miami Springs	Florida
United States	Comprehensive Phase One	Miramar	Florida
United States	Aspen Clinical Research	Orem	Utah
United States	Compass Research, LLC	Orlando	Florida
United States	Princeton Medical Institutes	Princeton	New Jersey
United States	San Francisco Clinical Research Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Targacept Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Number of participants with treatment-emergent adverse events	Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14	Yes
Secondary	Pharmacokinetic profiles	Plasma concentrations (pharmacokinetic profiles) of TC-5619-238 over time (Groups 1 & 2) and urine (Group 2) samples after multiple doses	Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14	No
Secondary	Markers of inflammation in cerebrospinal fluid	Changes in markers of inflammation in cerebrospinal fluid (Group 1 only)	Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14	No
Secondary	Markers of inflammation in plasma	Dose related changes in markers of inflammation in plasma over time (Groups 1 & 2)	Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14	No