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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01254448
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : September 4, 2013
Information provided by (Responsible Party):
Targacept Inc.

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: TC-5619 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]
    Number of participants with treatment-emergent adverse events

Secondary Outcome Measures :
  1. Pharmacokinetic profiles [ Time Frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 ]
    Plasma concentrations (pharmacokinetic profiles) of TC-5619-238 over time (Groups 1 & 2) and urine (Group 2) samples after multiple doses

  2. Markers of inflammation in cerebrospinal fluid [ Time Frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 ]
    Changes in markers of inflammation in cerebrospinal fluid (Group 1 only)

  3. Markers of inflammation in plasma [ Time Frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14 ]
    Dose related changes in markers of inflammation in plasma over time (Groups 1 & 2)

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01254448

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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.
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Principal Investigator: George Gerson, MD Comprehensive Phase One
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Responsible Party: Targacept Inc. Identifier: NCT01254448    
Other Study ID Numbers: TC-5619-238-CLP-003
First Posted: December 6, 2010    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013
Keywords provided by Targacept Inc.:
Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders