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Completed

NCT Number: NCT01254448

Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Network, Long Beach, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TC-5619

Drug

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

Drug

Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Targacept Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 6, 2010
Registry last updated
Sep 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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