Clinical trial NCT01254448: Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Lead sponsor: Targacept Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 38
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14
Secondary outcomes:
measure: Pharmacokinetic profiles
timeFrame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
measure: Markers of inflammation in cerebrospinal fluid
timeFrame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
measure: Markers of inflammation in plasma
timeFrame: Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: Miramar
country: United States
facility: Comprehensive Phase One
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center For Clinical Research
state: Georgia
city: Princeton
country: United States
facility: Princeton Medical Institutes
state: New Jersey
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
Study officials:
affiliation: Comprehensive Phase One
name: George Gerson, MD
role: PRINCIPAL_INVESTIGATOR
References: