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

NCT ID: NCT01254448

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

TC-5619

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

Group Type EXPERIMENTAL

TC-5619

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Targacept Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Gerson, MD

Role: PRINCIPAL_INVESTIGATOR

Comprehensive Phase One

Locations

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Collaborative Neuroscience Network

Long Beach, California, United States

Site Status

San Francisco Clinical Research Center

San Francisco, California, United States

Site Status

MD Clinical

Hallandale, Florida, United States

Site Status

Galiz Research

Miami Springs, Florida, United States

Site Status

Comprehensive Phase One

Miramar, Florida, United States

Site Status

Compass Research, LLC

Orlando, Florida, United States

Site Status

Atlanta Center For Clinical Research

Atlanta, Georgia, United States

Site Status

Princeton Medical Institutes

Princeton, New Jersey, United States

Site Status

Community Clinical Research

Austin, Texas, United States

Site Status

Aspen Clinical Research

Orem, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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TC-5619-238-CLP-003

Identifier Type: -

Identifier Source: org_study_id