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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TC-5619
Placebo
Sponsored by
Targacept Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Alzheimer's Disease

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Collaborative Neuroscience Network
  • San Francisco Clinical Research Center
  • MD Clinical
  • Galiz Research
  • Comprehensive Phase One
  • Compass Research, LLC
  • Atlanta Center For Clinical Research
  • Princeton Medical Institutes
  • Community Clinical Research
  • Aspen Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

TC-5619

Arm Description

Subjects will receive a placebo capsule orally once a day for 28 days (Group 1) or 10 days (Group 2).

Subjects will receive a TC-5619 orally once a day for 28 days (Group 1) or 10 days (Group 2).

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of participants with treatment-emergent adverse events

Secondary Outcome Measures

Pharmacokinetic profiles
Plasma concentrations (pharmacokinetic profiles) of TC-5619-238 over time (Groups 1 & 2) and urine (Group 2) samples after multiple doses
Markers of inflammation in cerebrospinal fluid
Changes in markers of inflammation in cerebrospinal fluid (Group 1 only)
Markers of inflammation in plasma
Dose related changes in markers of inflammation in plasma over time (Groups 1 & 2)

Full Information

First Posted
December 2, 2010
Last Updated
September 3, 2013
Sponsor
Targacept Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01254448
Brief Title
Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Targacept Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a placebo capsule orally once a day for 28 days (Group 1) or 10 days (Group 2).
Arm Title
TC-5619
Arm Type
Experimental
Arm Description
Subjects will receive a TC-5619 orally once a day for 28 days (Group 1) or 10 days (Group 2).
Intervention Type
Drug
Intervention Name(s)
TC-5619
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Number of participants with treatment-emergent adverse events
Time Frame
Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14
Secondary Outcome Measure Information:
Title
Pharmacokinetic profiles
Description
Plasma concentrations (pharmacokinetic profiles) of TC-5619-238 over time (Groups 1 & 2) and urine (Group 2) samples after multiple doses
Time Frame
Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
Title
Markers of inflammation in cerebrospinal fluid
Description
Changes in markers of inflammation in cerebrospinal fluid (Group 1 only)
Time Frame
Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
Title
Markers of inflammation in plasma
Description
Dose related changes in markers of inflammation in plasma over time (Groups 1 & 2)
Time Frame
Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Gerson, MD
Organizational Affiliation
Comprehensive Phase One
Official's Role
Principal Investigator
Facility Information:
Facility Name
Collaborative Neuroscience Network
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Galiz Research
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Comprehensive Phase One
City
Miramar
State/Province
Florida
ZIP/Postal Code
333025
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Atlanta Center For Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Princeton Medical Institutes
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States

12. IPD Sharing Statement

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

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