Status:
COMPLETED
Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly
Lead Sponsor:
Cerecin
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-85 years
Brief Summary
AC-1202 (Ketasyn) is a nutritional beverage currently being studied in neurodegenerative conditions including Alzheimer's disease. The current study is a randomized, open-label trial to compare the sa...
Detailed Description
Sixty healthy, elderly volunteers between the ages of 55 and 85 will be enrolled at one of four clinical sites in the Tampa/St. Petersburg area. Subjects with a history of GI inflammatory conditions (...
Eligibility Criteria
Inclusion
- No clinically significant abnormal findings on physical exam, vital signs, medical history, ECG, or laboratory results
Exclusion
- Type 1 or uncontrolled Type 2 diabetes
- History of or current inflammation of GI system, e.g. IBS, diverticular disease, gastric or duodenal ulcers, severe GERD requiring daily medication
- History (within past 60 days) of infections
- Clinically significant renal, hepatic, or hematologic abnormalities
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00660088
Start Date
April 1 2008
End Date
August 1 2008
Last Update
October 8 2008
Active Locations (1)
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1
Meridien Research Center
St. Petersburg, Florida, United States, 33709