An observational study in Alzheimer's Disease, sponsored by Cerecin. Completed at 1 site in United States. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-08.
Sponsored by Cerecin · Observational
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.
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 (e.g., IBS or diverticulitis) or other clinically significant abnormalities will be excluded from enrollment. Subjects will be randomized to one of two dosing regimens (with or without a 7-day titration period) and to one of three formulations of Ketasyn containing the identical amount of active ingredient, but different amounts of proteins and carbohydrates. Subjects assigned to Group 1 will receive 10 grams active ingredient daily on Days 1-7, followed by a daily dose of 20 grams active ingredient on Days 8-14. Subjects assigned to Group 2 will receive 20 grams active ingredient on Days 1-14. All subjects will have clinic visits on Day 1 and 14; subjects assigned to Group 1 will also have a clinic visit on Day 8. Subjects will fast prior to each clinic visit and have vital signs and routine lab tests performed prior to dosing. A standard breakfast will be served along with the study product, following which blood samples will be collected for product concentration levels.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 780 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Cerecin is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Healthy elderly male and female subjects 55 - 85 years of age
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
10 gram x 7 days, then 20 gram x 7 days active ingredient of original formulation
Other: Ketasyn
20 grams x 14 days active ingredient of original formulation
Other: Ketasyn
10 grams x 7 days; then 20 grams x 7 days of low protein formulation
Other: Ketasyn
20 grams x 14 days of low protein formulation
Other: Ketasyn
10 grams x 7 days; then 20 grams x 7 days of high protein formulation
Other: Ketasyn
20 grams x 14 days of high protein formulation
Other: Ketasyn
10g for 7 days, 20g for 7 or 14 days
Plasma peak concentration levels and AUC
Time frame: two weeks
Incidence and severity of adverse events
Time frame: 3 weeks
The record gives a start of Apr 2008, a primary completion of Jun 2008 and a completion of Aug 2008. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Cerecin