Status:
COMPLETED
Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
Lead Sponsor:
Targacept Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-80 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01254448
Start Date
September 1 2010
End Date
May 1 2011
Last Update
September 4 2013
Active Locations (10)
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1
Collaborative Neuroscience Network
Long Beach, California, United States, 90806
2
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
3
MD Clinical
Hallandale, Florida, United States, 33009
4
Galiz Research
Miami Springs, Florida, United States, 33166