Alzheimer's Disease
Conditions
Keywords
Alzheimer's Disease
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.
Interventions
DRUGTC-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.
DRUGPlacebo
Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.
Sponsors
Targacept Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profiles | 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 |
| Markers of inflammation in cerebrospinal fluid | 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) |
| Markers of inflammation in plasma | 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) |
Countries
United States
Outcome results
None listed