Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly

Completed

Conditions studied: Alzheimer's Disease

In brief

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 safety, tolerability, and PK profiles of 3 formulations of Ketasyn administered on a daily basis for 14 days, with and without a 7-day titration period, in normal, healthy elderly volunteers.

Key facts

Study ID

NCT00660088

Run by

Cerecin

People needed

60

Starts

2008-04-01

Expected to finish

2008-08-01

Last updated by the study team

2008-10-08

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on physical exam, vital signs, medical history, ECG, or laboratory results

You may not qualify if…

• 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

Where it is running

• Meridien Research Center — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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