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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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: TC-5619
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Targacept Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 38
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects will receive a placebo capsule orally once a day for 28 days (Group 1) or 10 days (Group 2).
Drug: Placebo
Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.
Experimental: TC-5619
Subjects will receive a TC-5619 orally once a day for 28 days (Group 1) or 10 days (Group 2).
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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254448

Locations
United States, California
Collaborative Neuroscience Network
Long Beach, California, United States, 90806
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Galiz Research
Miami Springs, Florida, United States, 33166
Comprehensive Phase One
Miramar, Florida, United States, 333025
Compass Research, LLC
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta Center For Clinical Research
Atlanta, Georgia, United States, 30308
United States, New Jersey
Princeton Medical Institutes
Princeton, New Jersey, United States, 08540
United States, Texas
Community Clinical Research
Austin, Texas, United States, 78754
United States, Utah
Aspen Clinical Research
Orem, Utah, United States, 84058
Sponsors and Collaborators
Targacept Inc.
Investigators
Principal Investigator: George Gerson, MD Comprehensive Phase One
  More Information

No publications provided

Responsible Party: Targacept Inc.
ClinicalTrials.gov Identifier: NCT01254448     History of Changes
Other Study ID Numbers: TC-5619-238-CLP-003
Study First Received: December 2, 2010
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Targacept Inc.:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014