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

Targacept Inc.38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

TC-5619DRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (10)

Collaborative Neuroscience Network

Long Beach, California, United States

San Francisco Clinical Research Center

San Francisco, California, United States

MD Clinical

Hallandale, Florida, United States

Outcomes

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Number of participants with treatment-emergent adverse events

Time frame: Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14

Secondary Outcomes

Pharmacokinetic profiles

Plasma concentrations (pharmacokinetic profiles) of TC-5619-238 over time (Groups 1 \& 2) and urine (Group 2) samples after multiple doses

Time frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14

Markers of inflammation in cerebrospinal fluid

Changes in markers of inflammation in cerebrospinal fluid (Group 1 only)

Time frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14

Markers of inflammation in plasma

Dose related changes in markers of inflammation in plasma over time (Groups 1 \& 2)

Time frame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14

Data from ClinicalTrials.gov

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