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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Targacept Inc.
ClinicalTrials.gov Identifier:
NCT01254448
First received: December 2, 2010
Last updated: September 3, 2013
Last verified: September 2013

December 2, 2010
September 3, 2013
September 2010
March 2011   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14 ] [ Designated as safety issue: Yes ]
Number of participants with treatment-emergent adverse events
Same as current
Complete list of historical versions of study NCT01254448 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic profiles [ Time Frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 ] [ Designated as safety issue: No ]
    Changes in markers of inflammation in cerebrospinal fluid (Group 1 only)
  • Markers of inflammation in plasma [ Time Frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 ] [ Designated as safety issue: No ]
    Dose related changes in markers of inflammation in plasma over time (Groups 1 & 2)
  • Pharmacokinetic profiles [ Time Frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 ] [ Designated as safety issue: Yes ]
    Plasma concentrations (pharmacokinetic profiles) of TC-5619-238 over time (Groups 1 & 2) and urine (Group 2) samples after multipe doses
  • Markers of inflammation in cerebrospinal fluid [ Time Frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 ] [ Designated as safety issue: No ]
    Changes in markers of inflammation in cerebrospinal fluid (Group 1 only)
  • Markers of inflammation in plasma [ Time Frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 ] [ Designated as safety issue: No ]
    Dose related changes in markers of inflammation in plasma over time (Groups 1 & 2)
Not Provided
Not Provided
 
Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Alzheimer's Disease
  • 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.
  • Drug: Placebo
    Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.
  • Placebo Comparator: Placebo
    Subjects will receive a placebo capsule orally once a day for 28 days (Group 1) or 10 days (Group 2).
    Intervention: Drug: Placebo
  • Experimental: TC-5619
    Subjects will receive a TC-5619 orally once a day for 28 days (Group 1) or 10 days (Group 2).
    Intervention: Drug: TC-5619
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
May 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
55 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01254448
TC-5619-238-CLP-003
No
Targacept Inc.
Targacept Inc.
Not Provided
Principal Investigator: George Gerson, MD Comprehensive Phase One
Targacept Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP